The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Johnson & Johnson Dual Syringe Applicator.
Device ID | K902157 |
510k Number | K902157 |
Device Name: | JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR |
Classification | Syringe, Piston |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 -3130 |
Contact | Richard J Skalski |
Correspondent | Richard J Skalski JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 -3130 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-15 |
Decision Date | 1990-11-29 |