The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Blakemore Retainer.
| Device ID | K880253 |
| 510k Number | K880253 |
| Device Name: | BLAKEMORE RETAINER |
| Classification | Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Robert R Moore |
| Correspondent | Robert R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | FEF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-03-11 |