The following data is part of a premarket notification filed by Faulding Medical Device Co. with the FDA for Safe-connect Y-site Adapter Catalog No. 681518.
Device ID | K971266 |
510k Number | K971266 |
Device Name: | SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 |
Classification | Set, Administration, Intravascular |
Applicant | FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
Contact | Bruce Craney |
Correspondent | Bruce Craney FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-04 |
Decision Date | 1997-05-01 |