The following data is part of a premarket notification filed by National-standard Medical Products with the FDA for Kopans Stabilized Needle Aspiration Guide (snag).
| Device ID | K896605 |
| 510k Number | K896605 |
| Device Name: | KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | NATIONAL-STANDARD MEDICAL PRODUCTS 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
| Contact | Steven R Robinson |
| Correspondent | Steven R Robinson NATIONAL-STANDARD MEDICAL PRODUCTS 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1990-01-04 |