The following data is part of a premarket notification filed by Micro-medical Devices, Inc. with the FDA for Endoscopes, Fiber Optic Laparoscopes, (sterilizable).
| Device ID | K951482 |
| 510k Number | K951482 |
| Device Name: | ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Contact | Edwin L Adair |
| Correspondent | Edwin L Adair MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-30 |
| Decision Date | 1995-09-14 |