The following data is part of a premarket notification filed by Micro Medical Devices, Inc. with the FDA for Laparoscopes.
Device ID | K936195 |
510k Number | K936195 |
Device Name: | LAPAROSCOPES |
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 | 1993-12-29 |
Decision Date | 1994-08-17 |