The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for The Gripper(tm) Port-a-cath Needles.
Device ID | K870866 |
510k Number | K870866 |
Device Name: | THE GRIPPER(TM) PORT-A-CATH NEEDLES |
Classification | Set, Administration, Intravascular |
Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Contact | Albert P Mayo |
Correspondent | Albert P Mayo PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1987-06-25 |