The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Bio-cut Soft Tissue Biopsy Needle.
| Device ID | K052802 |
| 510k Number | K052802 |
| Device Name: | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 241 WEST PALATINE RD. Wheeling, IL 60090 |
| Contact | Nicohl R Wilding |
| Correspondent | Nicohl R Wilding MANAN MEDICAL PRODUCTS, INC. 241 WEST PALATINE RD. Wheeling, IL 60090 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2005-11-01 |
| Summary: | summary |