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FDA 510(k)

RESTRAINT, PROTECTIVE

K-Number: K801628 · 1980-08-07

ApplicantThe Owenby Co.
Decision Date1980-08-07
Product CodeIQK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RESTRAINT, PROTECTIVE is the device name listed in this FDA 510(k) record. The listed applicant is The Owenby Co.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801628. The device is classified under product code IQK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTRAINT, PROTECTIVE?

RESTRAINT, PROTECTIVE is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is The Owenby Co.. The 510(k) number is K801628.

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

RESTRAINT, PROTECTIVE received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801628.

Who is the listed applicant for RESTRAINT, PROTECTIVE?

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

What is the FDA product code for RESTRAINT, PROTECTIVE?

The FDA product code for RESTRAINT, PROTECTIVE is IQK.

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Other records listing The Owenby Co. 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.

K801626ARM SLINGK801532STOCKINETTE, STERILE TWO PLY W/PULL TABSK801627COVER, LIMBK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHEDK780764NON-STERILE FOLDED GAUZE

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Related Devices (Code: IQK)

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.

K930730DORMIE NECK SUPPORT SYSTEMThe Western Diagnostics Co.K926291SCHUL-TEC IMMOBILIZERMedical Emergency Support EquipmentK896042MEDICAL DISPOSABLE BEDDINGKeystone Veterinary Supplies, Inc.K895477NOVA PILLOWNova Health Systems, Inc.K882264BATTLE CREEK PILLOWBattle Creek Equipment Co.K850465CERVICAL COLLARS & HEAD HALTERSAbco Dealers, Inc.

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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