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FDA 510(k)

PROVEST-PROTECTIVE RESTRAINT

K-Number: K971561 · 1997-07-14

ApplicantJemm Medical Products
Decision Date1997-07-14
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROVEST-PROTECTIVE RESTRAINT is the device name listed in this FDA 510(k) record. The listed applicant is Jemm Medical Products. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K971561. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVEST-PROTECTIVE RESTRAINT?

PROVEST-PROTECTIVE RESTRAINT is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Jemm Medical Products. The 510(k) number is K971561.

When did PROVEST-PROTECTIVE RESTRAINT receive FDA 510(k) clearance?

PROVEST-PROTECTIVE RESTRAINT received FDA 510(k) clearance on 1997-07-14, under 510(k) number K971561.

Who is the listed applicant for PROVEST-PROTECTIVE RESTRAINT?

The FDA 510(k) record lists Jemm Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROVEST-PROTECTIVE RESTRAINT?

The FDA product code for PROVEST-PROTECTIVE RESTRAINT is FMQ.

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Related Devices (Code: FMQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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