The following data is part of a premarket notification filed by Becton Dickinson Consumer Products with the FDA for Ace Sports Tape.
Device ID | K941379 |
510k Number | K941379 |
Device Name: | ACE SPORTS TAPE |
Classification | Tape And Bandage, Adhesive |
Applicant | BECTON DICKINSON CONSUMER PRODUCTS ONE BECTON DR. Franklin Lake, NJ 07417 -1883 |
Contact | Don A Cutshall |
Correspondent | Don A Cutshall BECTON DICKINSON CONSUMER PRODUCTS ONE BECTON DR. Franklin Lake, NJ 07417 -1883 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-22 |
Decision Date | 1994-06-13 |