The following data is part of a premarket notification filed by Cr Enterprises, Llc. with the FDA for Res-q Infant Wedge And Sling.
| Device ID | K090284 |
| 510k Number | K090284 |
| Device Name: | RES-Q INFANT WEDGE AND SLING |
| Classification | Holder, Infant Position |
| Applicant | CR ENTERPRISES, LLC. 4701 AUGUSTA DR. Frisco, TX 75034 -6839 |
| Contact | Craig A Troop |
| Correspondent | Craig A Troop CR ENTERPRISES, LLC. 4701 AUGUSTA DR. Frisco, TX 75034 -6839 |
| Product Code | FRP |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-06-05 |
| Summary: | summary |