The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Pediatric Position Holder.
| Device ID | K810609 |
| 510k Number | K810609 |
| Device Name: | PEDIATRIC POSITION HOLDER |
| Classification | Holder, Infant Position |
| Applicant | KAYE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-06 |
| Decision Date | 1981-03-20 |