The following data is part of a premarket notification filed by Pedia Pals, Inc. with the FDA for Speculum, Ent (s3).
| Device ID | K951049 |
| 510k Number | K951049 |
| Device Name: | SPECULUM, ENT (S3) |
| Classification | Otoscope |
| Applicant | PEDIA PALS, INC. 3939 INTERNATIONAL GATEWAY Columbus, OH 43219 |
| Contact | David L Barnes |
| Correspondent | David L Barnes PEDIA PALS, INC. 3939 INTERNATIONAL GATEWAY Columbus, OH 43219 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-04-17 |