The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Alimed Positioning 7 Safety Straps (three Types), Universal Cr/mri Wide Body Strap, Universal Ct Scanner Strap (2 Sizes).
| Device ID | K963528 |
| 510k Number | K963528 |
| Device Name: | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) |
| Classification | Restraint, Protective |
| Applicant | ALIMED, INC. 1200 EAST ST. Dedham, MA 02026 |
| Contact | Donal A Lincoln |
| Correspondent | Donal 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 | 1996-10-29 |
| Summary: | summary |