Depuy Orthotech Heavy Duty Vest Restraint
FDA 510(k) K971742 · Depuy, Inc.
510(k) numberK971742
Submission
- Device name
- Depuy Orthotech Heavy Duty Vest Restraint
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- May 12, 1997
- Decision date
- July 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMQ – Restraint, Protective
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6760
- Specialty
- General Hospital
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Questions and answers
When was Depuy Orthotech Heavy Duty Vest Restraint cleared by the FDA?
Depuy Orthotech Heavy Duty Vest Restraint (K971742) received a 510(k) decision of Substantially Equivalent on July 24, 1997, 73 days after the submission was received.
What is the product code of K971742?
The FDA product code is FMQ – Restraint, Protective, a Class I (low risk) device regulated under 21 CFR 880.6760.