The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R And D Batteries, Inc. Part Nos. 5038 & 5347.
| Device ID | K933491 |
| 510k Number | K933491 |
| Device Name: | R AND D BATTERIES, INC. PART NOS. 5038 & 5347 |
| Classification | Stimulator, Nerve |
| 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 | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-15 |
| Decision Date | 1993-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810149092213 | K933491 | 000 |
| 00810149091063 | K933491 | 000 |
| 00810149090301 | K933491 | 000 |