The following data is part of a premarket notification filed by National-standard Medical Products with the FDA for Jackson Fine Needle Aspiration System.
Device ID | K896606 |
510k Number | K896606 |
Device Name: | JACKSON FINE NEEDLE ASPIRATION SYSTEM |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | NATIONAL-STANDARD MEDICAL PRODUCTS 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
Contact | Robinson |
Correspondent | 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 |