The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Techna-cut Aspiration Needle.
| Device ID | K943651 |
| 510k Number | K943651 |
| Device Name: | TECHNA-CUT ASPIRATION NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Fred Mittermeier |
| Correspondent | Fred Mittermeier MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1994-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813079020018 | K943651 | 000 |