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FDA 510(k)

SWEEN UNIVERSAL BED RAIL PADS

K-Number: K810846 · 1981-04-17

ApplicantSween Corp.
Decision Date1981-04-17
Product CodeFNJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SWEEN UNIVERSAL BED RAIL PADS is the device name listed in this FDA 510(k) record. The listed applicant is Sween Corp.. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K810846. The device is classified under product code FNJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWEEN UNIVERSAL BED RAIL PADS?

SWEEN UNIVERSAL BED RAIL PADS is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Sween Corp.. The 510(k) number is K810846.

When did SWEEN UNIVERSAL BED RAIL PADS receive FDA 510(k) clearance?

SWEEN UNIVERSAL BED RAIL PADS received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810846.

Who is the listed applicant for SWEEN UNIVERSAL BED RAIL PADS?

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

What is the FDA product code for SWEEN UNIVERSAL BED RAIL PADS?

The FDA product code for SWEEN UNIVERSAL BED RAIL PADS is FNJ.

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Other records listing Sween 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.

K926389SWEEN WOUND CARE-COLLAGEN WOUND DRESSINGK912506CRITIC-AID WOUND DRESSINGK840723SWEEN-A-PEEL PERISTOMAL WAFERS

Related Devices (Code: FNJ)

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.

K934298KING KRIBNoritage, Inc.K892877CRADLE, HOSPITAL BED CLOTHINGWarsaw Orthopedic, Inc.K885241BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MATKing Mfg. Co.K884542SIC 3999 FOLDING ADJUSTABLE HOSPITAL BEDCommercial Products & Engineering Co.K881725ENVIROTENT (BED)Envirotents, Inc.K881961MSI STANDARD BED MODELS: L1097-64 AND L1085-64Med Service, 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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