The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Biohole Needle With Capick Scab Remover.
| Device ID | K100520 |
| 510k Number | K100520 |
| Device Name: | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER |
| Classification | Needle, Fistula |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-23 |
| Decision Date | 2010-03-17 |
| Summary: | summary |