The following data is part of a premarket notification filed by Johnson & Johnson Patient Care, Inc. with the FDA for Johnson & Johnson Sterile Spray Tip Syringe.
Device ID | K884749 |
510k Number | K884749 |
Device Name: | JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE |
Classification | Syringe, Irrigating (non Dental) |
Applicant | JOHNSON & JOHNSON PATIENT CARE, INC. New Brunswick, NJ 08903 |
Contact | Richard J Skalski |
Correspondent | Richard J Skalski JOHNSON & JOHNSON PATIENT CARE, INC. New Brunswick, NJ 08903 |
Product Code | KYZ |
CFR Regulation Number | 880.6960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-14 |
Decision Date | 1988-12-15 |