The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fb Series Biopsy Forceps.
Device ID | K962555 |
510k Number | K962555 |
Device Name: | OLYMPUS FB SERIES BIOPSY FORCEPS |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Barry E Sands |
Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-01 |
Decision Date | 1996-07-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170078214 | K962555 | 000 |
14953170030007 | K962555 | 000 |
14953170029971 | K962555 | 000 |
14953170029957 | K962555 | 000 |
14953170029933 | K962555 | 000 |
14953170029889 | K962555 | 000 |
14953170029827 | K962555 | 000 |
14953170029773 | K962555 | 000 |
14953170029759 | K962555 | 000 |
14953170029728 | K962555 | 000 |
14953170029698 | K962555 | 000 |
14953170029667 | K962555 | 000 |
14953170029643 | K962555 | 000 |
14953170029629 | K962555 | 000 |
14953170029605 | K962555 | 000 |
14953170029582 | K962555 | 000 |
14953170029551 | K962555 | 000 |
14953170029537 | K962555 | 000 |
14953170030052 | K962555 | 000 |
14953170030083 | K962555 | 000 |
14953170030984 | K962555 | 000 |
14953170030625 | K962555 | 000 |
14953170030540 | K962555 | 000 |
14953170030526 | K962555 | 000 |
14953170030496 | K962555 | 000 |
14953170030441 | K962555 | 000 |
14953170030373 | K962555 | 000 |
14953170030342 | K962555 | 000 |
14953170030311 | K962555 | 000 |
14953170030298 | K962555 | 000 |
14953170030267 | K962555 | 000 |
14953170030236 | K962555 | 000 |
14953170030212 | K962555 | 000 |
14953170030182 | K962555 | 000 |
14953170030168 | K962555 | 000 |
14953170030144 | K962555 | 000 |
14953170030113 | K962555 | 000 |
14953170029506 | K962555 | 000 |