The following data is part of a premarket notification filed by Medcomp Technologies, Inc. with the FDA for Medcare Suture Scissors (suture/gauze Weight).
| Device ID | K861806 |
| 510k Number | K861806 |
| Device Name: | MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) |
| Classification | Prosthesis, Ptfe/carbon-fiber |
| Applicant | MEDCOMP TECHNOLOGIES, INC. 2555 BAIRD RD. Penfield, NY 14526 |
| Contact | Wildeman |
| Correspondent | Wildeman MEDCOMP TECHNOLOGIES, INC. 2555 BAIRD RD. Penfield, NY 14526 |
| Product Code | KDA |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-09 |
| Decision Date | 1986-05-23 |