The following data is part of a premarket notification filed by Pedicraft, Inc. with the FDA for Infant Reflux Sling.
| Device ID | K905630 |
| 510k Number | K905630 |
| Device Name: | INFANT REFLUX SLING |
| Classification | Holder, Infant Position |
| Applicant | PEDICRAFT, INC. 2014 PERRY PLACE Jacksonville, FL 32207 |
| Contact | Eric Nord |
| Correspondent | Eric Nord PEDICRAFT, INC. 2014 PERRY PLACE Jacksonville, FL 32207 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-03-13 |