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FDA 510(k)

CENTURION PROTECTIVE RESTRAINT, SCR SERIES

K-Number: K080448 · 2008-08-28

ApplicantTri-State Hospital Supply Corp.
Decision Date2008-08-28
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CENTURION PROTECTIVE RESTRAINT, SCR SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Tri-State Hospital Supply Corp.. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K080448. 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 CENTURION PROTECTIVE RESTRAINT, SCR SERIES?

CENTURION PROTECTIVE RESTRAINT, SCR SERIES is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Tri-State Hospital Supply Corp.. The 510(k) number is K080448.

When did CENTURION PROTECTIVE RESTRAINT, SCR SERIES receive FDA 510(k) clearance?

CENTURION PROTECTIVE RESTRAINT, SCR SERIES received FDA 510(k) clearance on 2008-08-28, under 510(k) number K080448.

Who is the listed applicant for CENTURION PROTECTIVE RESTRAINT, SCR SERIES?

The FDA 510(k) record lists Tri-State Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTURION PROTECTIVE RESTRAINT, SCR SERIES?

The FDA product code for CENTURION PROTECTIVE RESTRAINT, SCR SERIES is FMQ.

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Other records listing Tri-State Hospital Supply Corp. as applicant

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.

K080524CENTURION SORBAVIEW OTCK942353CENTURION UMBILICAL CATHETERK945977CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSINGK931748CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYSK935491CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)K923812CENTURION DISPOSABLE INSTRUMENTS

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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.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.K991591BIOTHANE PATIENT RESTRAINTBioplastics

Official Source

View on FDA Database →

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

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