The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Bipolard Polypectomy System (tm).
| Device ID | K901302 |
| 510k Number | K901302 |
| Device Name: | BIPOLARD POLYPECTOMY SYSTEM (TM) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-06-06 |