The following data is part of a premarket notification filed by Pedia Pals, Inc. with the FDA for Pedia Pals, Incorporated.
| Device ID | K950086 |
| 510k Number | K950086 |
| Device Name: | PEDIA PALS, INCORPORATED |
| Classification | Speculum, Ent |
| 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 | EPY |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-02-07 |