The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for A4722 Olympus Optical Obturator.
Device ID | K950055 |
510k Number | K950055 |
Device Name: | A4722 OLYMPUS OPTICAL OBTURATOR |
Classification | Hysteroscope (and Accessories) |
Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
Contact | Barry E Sands |
Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-06 |
Decision Date | 1995-02-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04042761006682 | K950055 | 000 |
04042761006521 | K950055 | 000 |