The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Instrument Makar Disposalbe Loop.
| Device ID | K853597 |
| 510k Number | K853597 |
| Device Name: | INSTRUMENT MAKAR DISPOSALBE LOOP |
| Classification | Instrument, Surgical, Disposable |
| Applicant | INSTRUMENT MAKAR, INC. 815 CONNECTICUT AVE. Washington, DC 20006 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INSTRUMENT MAKAR, INC. 815 CONNECTICUT AVE. Washington, DC 20006 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-27 |
| Decision Date | 1985-09-23 |