The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Automatic Cutting Needle.
| Device ID | K974446 |
| 510k Number | K974446 |
| Device Name: | MANAN AUTOMATIC CUTTING NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Michael Plishka |
| Correspondent | Michael Plishka 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 | 1997-11-25 |
| Decision Date | 1998-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333007398 | K974446 | 000 |
| 20886333007251 | K974446 | 000 |
| 20886333007268 | K974446 | 000 |
| 20886333007275 | K974446 | 000 |
| 20886333007282 | K974446 | 000 |
| 20886333007299 | K974446 | 000 |
| 20886333007305 | K974446 | 000 |
| 20886333007312 | K974446 | 000 |
| 20886333007329 | K974446 | 000 |
| 20886333007336 | K974446 | 000 |
| 20886333007343 | K974446 | 000 |
| 20886333007350 | K974446 | 000 |
| 20886333007367 | K974446 | 000 |
| 20886333007374 | K974446 | 000 |
| 20886333007381 | K974446 | 000 |
| 20886333007237 | K974446 | 000 |