The following data is part of a premarket notification filed by Esco Precision, Inc. with the FDA for Non-electric Biopsy Forceps.
Device ID | K900015 |
510k Number | K900015 |
Device Name: | NON-ELECTRIC BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Non-electric |
Applicant | ESCO PRECISION, INC. 21 WILLIAM PENN DR. Stony Brook, NY 11790 |
Contact | Ted Esser |
Correspondent | Ted Esser ESCO PRECISION, INC. 21 WILLIAM PENN DR. Stony Brook, NY 11790 |
Product Code | FCL |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-02 |
Decision Date | 1990-03-15 |