The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for 1x6yd, 2x6yd, 4x6yd Roll Bandage.
| Device ID | K945002 |
| 510k Number | K945002 |
| Device Name: | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE |
| Classification | Gauze/sponge, Internal |
| Applicant | CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Contact | Howard Freeman |
| Correspondent | Howard Freeman 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 | 1994-10-13 |
| Decision Date | 1995-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766588110271 | K945002 | 000 |
| 00766588110240 | K945002 | 000 |
| 00766588312132 | K945002 | 000 |
| 00766588312118 | K945002 | 000 |
| 00766588312101 | K945002 | 000 |
| 00766588312095 | K945002 | 000 |
| 00766588312057 | K945002 | 000 |
| 00766588110110 | K945002 | 000 |