The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Disposable Biopsy Forceps.
Device ID | K930241 |
510k Number | K930241 |
Device Name: | OLYMPUS DISPOSABLE BIOPSY FORCEPS |
Classification | Instrument, Biopsy |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Barry E Sands |
Correspondent | Barry E Sands OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1993-04-20 |