The following data is part of a premarket notification filed by Frantz Medical Development, Ltd. with the FDA for Biopsy Forceps.
Device ID | K871710 |
510k Number | K871710 |
Device Name: | BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Non-electric |
Applicant | FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
Contact | Mark G Frantz |
Correspondent | Mark G Frantz FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
Product Code | FCL |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-01 |
Decision Date | 1987-08-10 |