The following data is part of a premarket notification filed by O.r. Solutions, Inc. with the FDA for 1075ld Hush-slush.
| Device ID | K023283 |
| 510k Number | K023283 |
| Device Name: | 1075LD HUSH-SLUSH |
| Classification | Warmer, Irrigation Solution |
| Applicant | O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W Chantilly, VA 20151 -1689 |
| Contact | Steve Hannes |
| Correspondent | Steve Hannes O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W Chantilly, VA 20151 -1689 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2002-11-13 |