The following data is part of a premarket notification filed by E.m. Adams with the FDA for Sterile Suture Removal Kit.
| Device ID | K812132 |
| 510k Number | K812132 |
| Device Name: | STERILE SUTURE REMOVAL KIT |
| Classification | Suture Removal Kit |
| Applicant | E.M. ADAMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | MCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-28 |
| Decision Date | 1981-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58100013402895 | K812132 | 000 |
| 50840200300570 | K812132 | 000 |
| 50840200300556 | K812132 | 000 |
| 50840200300532 | K812132 | 000 |
| 10840200300527 | K812132 | 000 |
| 50840200300495 | K812132 | 000 |
| 50840200302895 | K812132 | 000 |
| 50840200302871 | K812132 | 000 |
| 50840200302857 | K812132 | 000 |
| 50840200302833 | K812132 | 000 |
| 50840200302819 | K812132 | 000 |
| 50840200302796 | K812132 | 000 |
| 50840200302772 | K812132 | 000 |
| 50840200302734 | K812132 | 000 |
| 50840200300594 | K812132 | 000 |
| 58100013400495 | K812132 | 000 |
| 58100013402871 | K812132 | 000 |
| 58100013402857 | K812132 | 000 |
| 58100013402833 | K812132 | 000 |
| 58100013402819 | K812132 | 000 |
| 58100013402796 | K812132 | 000 |
| 58100013402772 | K812132 | 000 |
| 58100013402734 | K812132 | 000 |
| 58100013402710 | K812132 | 000 |
| 58100013400594 | K812132 | 000 |
| 58100013400570 | K812132 | 000 |
| 58100013400556 | K812132 | 000 |
| 58100013400532 | K812132 | 000 |
| 58100013400518 | K812132 | 000 |
| 50840200302710 | K812132 | 000 |