The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Economy Limb Holder,deluxe Limb Holder,cinch-type Limb Holder,padded Limb Holder,adjustable Limb Holder.
| Device ID | K963378 |
| 510k Number | K963378 |
| Device Name: | MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER |
| Classification | Restraint, Protective |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1996-10-29 |
| Summary: | summary |