The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Verrescope, Light Cable - Light Source Adaptor.
Device ID | K971836 |
510k Number | K971836 |
Device Name: | VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
Contact | Debra A Pekar |
Correspondent | Debra A Pekar COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-19 |
Decision Date | 1997-11-07 |
Summary: | summary |