The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for Replacement Batteries Part No. 5098,5135, 5097.
Device ID | K936018 |
510k Number | K936018 |
Device Name: | REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 |
Classification | Ophthalmoscope, Battery-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 | HLJ |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-16 |
Decision Date | 1994-02-22 |