The following data is part of a premarket notification filed by Concept, Inc. with the FDA for C-loops.
| Device ID | K830800 |
| 510k Number | K830800 |
| Device Name: | C-LOOPS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-10-04 |