The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R & D Batteries,inc. Part Numbers 5164, 5272, 5260.
Device ID | K933687 |
510k Number | K933687 |
Device Name: | R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | R & D BATTERIES, INC. P.O. BOX 5007 Burnsville, MN 55337 |
Contact | Randall C Noddings |
Correspondent | Randall C Noddings R & D BATTERIES, INC. P.O. BOX 5007 Burnsville, MN 55337 |
Product Code | FKX |
Subsequent Product Code | FAP |
Subsequent Product Code | FKP |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1994-02-09 |