The following data is part of a premarket notification filed by Micro-medical Devices, Inc. with the FDA for Laparaoscopes Electronic With Sterile Sheath.
| Device ID | K940141 |
| 510k Number | K940141 |
| Device Name: | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Contact | Edwin L Adair, M.d. |
| Correspondent | Edwin L Adair, M.d. 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 | 1994-01-11 |
| Decision Date | 1994-05-19 |