The following data is part of a premarket notification filed by Pryor Products with the FDA for Patient Pal I.v. Walker.
Device ID | K820963 |
510k Number | K820963 |
Device Name: | PATIENT PAL I.V. WALKER |
Classification | Stand, Infusion |
Applicant | PRYOR PRODUCTS 420 North Cedros Avenue Solana Beach, CA 92075 |
Contact | Mary Berry |
Correspondent | Mary Berry PRYOR PRODUCTS 420 North Cedros Avenue Solana Beach, CA 92075 |
Product Code | FOX |
CFR Regulation Number | 880.6990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-06 |
Decision Date | 1982-04-21 |