The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Disposable Aspiration Needle Na-200h.
Device ID | K023272 |
510k Number | K023272 |
Device Name: | DISPOSABLE ASPIRATION NEEDLE NA-200H |
Classification | Biopsy Needle |
Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-01 |
Decision Date | 2002-12-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170309233 | K023272 | 000 |
14953170169974 | K023272 | 000 |
14953170309097 | K023272 | 000 |
14953170309110 | K023272 | 000 |
14953170309134 | K023272 | 000 |
14953170309158 | K023272 | 000 |
14953170309172 | K023272 | 000 |
14953170309196 | K023272 | 000 |
14953170309219 | K023272 | 000 |
14953170169967 | K023272 | 000 |