The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for Gauze Compress.
| Device ID | K960615 |
| 510k Number | K960615 |
| Device Name: | GAUZE COMPRESS |
| Classification | Gauze/sponge, Internal |
| Applicant | CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Contact | Howard Gerson |
| Correspondent | Howard Gerson CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-13 |
| Decision Date | 1996-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766588110219 | K960615 | 000 |
| 00766588110172 | K960615 | 000 |
| 00766588110141 | K960615 | 000 |