The following data is part of a premarket notification filed by Ackard Laboratories with the FDA for Pao Value.
Device ID | K852990 |
510k Number | K852990 |
Device Name: | PAO VALUE |
Classification | Syringe, Piston |
Applicant | ACKARD LABORATORIES 70 JACKSON DR. P.O. BOX 1085 Cranford, NJ 07016 |
Contact | Bernard Ackerman |
Correspondent | Bernard Ackerman ACKARD LABORATORIES 70 JACKSON DR. P.O. BOX 1085 Cranford, NJ 07016 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-15 |
Decision Date | 1985-09-20 |