The following data is part of a premarket notification filed by Optik with the FDA for Optik Laparoscope.
Device ID | K933776 |
510k Number | K933776 |
Device Name: | OPTIK LAPAROSCOPE |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | OPTIK 1370 BLAIR DR. Odenton, MD 21113 |
Contact | William M Macfie |
Correspondent | William M Macfie OPTIK 1370 BLAIR DR. Odenton, MD 21113 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-03 |
Decision Date | 1994-03-16 |