The following data is part of a premarket notification filed by Medicon Instruments, Inc. with the FDA for Retractors, Speculum, Clip Applier For Titanium Clips, 2-way Stop Cock, Palpation Probe, Knot Guide, Roeder Loop.
| Device ID | K936250 |
| 510k Number | K936250 |
| Device Name: | RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-05-12 |