The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Universal Econo-strap, Qualcraft Universal Straps.
| Device ID | K963527 |
| 510k Number | K963527 |
| Device Name: | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS |
| Classification | Restraint, Protective |
| Applicant | ALIMED, INC. 1200 EAST ST. Dedham, MA 02026 |
| Contact | Donald A Lincoln |
| Correspondent | Donald A Lincoln ALIMED, INC. 1200 EAST ST. Dedham, MA 02026 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-04 |
| Decision Date | 1996-10-31 |
| Summary: | summary |