The following data is part of a premarket notification filed by Life Sensing Instrument Company, Inc. with the FDA for Apollo Camera.
Device ID | K931136 |
510k Number | K931136 |
Device Name: | APOLLO CAMERA |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | LIFE SENSING INSTRUMENT COMPANY, INC. 400 LONG BEACH BLVD. Stratford, CT 06615 |
Contact | Curtis Raymond |
Correspondent | Curtis Raymond LIFE SENSING INSTRUMENT COMPANY, INC. 400 LONG BEACH BLVD. Stratford, CT 06615 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-05 |
Decision Date | 1994-01-11 |