The following data is part of a premarket notification filed by Geriatric Products, Inc. with the FDA for Protective Restraint(models #302,440,750 And A30 X 30 Belt..
| Device ID | K972338 |
| 510k Number | K972338 |
| Device Name: | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. |
| Classification | Restraint, Protective |
| Applicant | GERIATRIC PRODUCTS, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith GERIATRIC PRODUCTS, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-23 |
| Decision Date | 1997-07-24 |