The following data is part of a premarket notification filed by N-s Medical Products with the FDA for Hawkins-akins Blunt Needle Access Kit.
Device ID | K881957 |
510k Number | K881957 |
Device Name: | HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT |
Classification | Instrument, Biopsy |
Applicant | N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville, FL 32608 |
Contact | Keith L Stahl |
Correspondent | Keith L Stahl N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville, FL 32608 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-10 |
Decision Date | 1988-05-20 |