The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fg-45/46-1 Grasping Forceps(urology).
Device ID | K962387 |
510k Number | K962387 |
Device Name: | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) |
Classification | Dislodger, Stone, Basket, Ureteral, Metal |
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 | FFL |
CFR Regulation Number | 876.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-20 |
Decision Date | 1996-07-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170031721 | K962387 | 000 |
14953170031707 | K962387 | 000 |
14953170031677 | K962387 | 000 |
14953170031653 | K962387 | 000 |