The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R&d Batteries, Part Nos. 5243, 5104, And 5481.
Device ID | K942033 |
510k Number | K942033 |
Device Name: | R&D BATTERIES, PART NOS. 5243, 5104, AND 5481 |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville, MN 55337 |
Contact | Randall C Noddings |
Correspondent | Randall C Noddings R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville, MN 55337 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-28 |
Decision Date | 1994-06-28 |