POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER— 510(k) K963431
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K963431 for POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER, Substantially Equivalent on 1996-11-06. Applicant: Zimmer, Inc.. Device class: 1.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code FMQ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6760
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dover, OH, US
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Adverse events under product code FMQ
product code FMQ- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.