The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Dobbhoff(r) Retrieval Forceps.
Device ID | K901744 |
510k Number | K901744 |
Device Name: | DOBBHOFF(R) RETRIEVAL FORCEPS |
Classification | Goniometer, Nonpowered |
Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
Contact | Peter Waeger |
Correspondent | Peter Waeger BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
Product Code | KQW |
CFR Regulation Number | 888.1520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-17 |
Decision Date | 1990-07-03 |