The following data is part of a premarket notification filed by Continental Medical Laboratories, Inc. with the FDA for Prod. No. 01-132 - Suture Removal Kit.
| Device ID | K964827 |
| 510k Number | K964827 |
| Device Name: | PROD. NO. 01-132 - SUTURE REMOVAL KIT |
| Classification | Suture Removal Kit |
| Applicant | CONTINENTAL MEDICAL LABORATORIES, INC. 817 WEST MOHR AVE. P.O. BOX 306 Waterford, WI 53185 |
| Contact | Joseph Dunn |
| Correspondent | Joseph Dunn CONTINENTAL MEDICAL LABORATORIES, INC. 817 WEST MOHR AVE. P.O. BOX 306 Waterford, WI 53185 |
| Product Code | MCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-02 |
| Decision Date | 1997-02-14 |