The following data is part of a premarket notification filed by National Custom Ent., Inc. with the FDA for Replacement Batteries/welch Allyn #72200 Power Handle.
| Device ID | K942244 |
| 510k Number | K942244 |
| Device Name: | REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE |
| Classification | Otoscope |
| Applicant | NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD. Burnsville, MN 55337 -2559 |
| Contact | Michael A Benyo |
| Correspondent | Michael A Benyo NATIONAL CUSTOM ENT., INC. 400 GATEWAY BLVD. Burnsville, MN 55337 -2559 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-29 |
| Decision Date | 1994-06-24 |