The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for 8 X 10 Non-stick Pad.
| Device ID | K940344 |
| 510k Number | K940344 |
| Device Name: | 8 X 10 NON-STICK PAD |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766588310039 | K940344 | 000 |
| 00766588110301 | K940344 | 000 |