The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Neurosponges.
Device ID | K812391 |
510k Number | K812391 |
Device Name: | NEUROSPONGES |
Classification | Gauze/sponge, Internal, X-ray Detectable |
Applicant | WINN HIRSCH & ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GDY |
CFR Regulation Number | 878.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-20 |
Decision Date | 1981-11-24 |