The following data is part of a premarket notification filed by Whitney Products, Inc. with the FDA for Surgical Curette.
Device ID | K932493 |
510k Number | K932493 |
Device Name: | SURGICAL CURETTE |
Classification | Curette, Surgical, General Use |
Applicant | WHITNEY PRODUCTS, INC. 1822 PICKWICK LN. Glenview, IL 60025 |
Contact | William Whitney |
Correspondent | William Whitney WHITNEY PRODUCTS, INC. 1822 PICKWICK LN. Glenview, IL 60025 |
Product Code | FZS |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-24 |
Decision Date | 1994-01-07 |