The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Laparoscopic Forceps.
Device ID | K911474 |
510k Number | K911474 |
Device Name: | LAPAROSCOPIC FORCEPS |
Classification | Forceps, Surgical, Gynecological |
Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
Contact | Dean Secrest |
Correspondent | Dean Secrest UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
Product Code | HCZ |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-04 |
Decision Date | 1991-07-03 |