# FDA 483 - OssDsign AB - Unknown Date

Source: https://www.keypedia.com/records/483/ossdsign-ab/46837d95-2a38-42d4-8fbe-8da15a069249

> FDA 483 for OssDsign AB on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OssDsign AB
- Product Type: device
- Office Name: Division of Advertising & Promotion 
- Summary: This document is a Q-Submission from Weissburg Associates on behalf of OssDsign AB concerning their OSSDIGN Cranial PSI (K161090), which is currently on an FDA hold. The submission requests guidance and clarification on several deficiencies identified by the FDA in a previous letter. OssDsign AB also requests that the submission and subsequent communications be held in confidence by the FDA, as per 21 CFR 807.95.

Company: https://www.keypedia.com/companies/ossdsign-ab/7144df41-0a6a-44ab-ba04-f1b1b67fd38b

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0