The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Hyf-p Flexible Hysterofiberscope.
Device ID | K891451 |
510k Number | K891451 |
Device Name: | OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE |
Classification | Hysteroscope (and Accessories) |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Joseph R Williams |
Correspondent | Joseph R Williams OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-15 |
Decision Date | 1989-10-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170340178 | K891451 | 000 |
04953170307089 | K891451 | 000 |
04953170058219 | K891451 | 000 |
04953170051128 | K891451 | 000 |
04953170411571 | K891451 | 000 |
04953170411090 | K891451 | 000 |