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FDA 510(k)

SOF-ROL CAST PADDING

K-Number: K820139 · 1982-02-05

ApplicantStan-Pak Ent.
Decision Date1982-02-05
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOF-ROL CAST PADDING is the device name listed in this FDA 510(k) record. The listed applicant is Stan-Pak Ent.. It received FDA 510(k) clearance on 1982-02-05 under 510(k) number K820139. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF-ROL CAST PADDING?

SOF-ROL CAST PADDING is a medical device that received FDA 510(k) clearance on 1982-02-05. The listed applicant is Stan-Pak Ent.. The 510(k) number is K820139.

When did SOF-ROL CAST PADDING receive FDA 510(k) clearance?

SOF-ROL CAST PADDING received FDA 510(k) clearance on 1982-02-05, under 510(k) number K820139.

Who is the listed applicant for SOF-ROL CAST PADDING?

The FDA 510(k) record lists Stan-Pak Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOF-ROL CAST PADDING?

The FDA product code for SOF-ROL CAST PADDING is NAB.

Related Clinical Trials

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Other records listing Stan-Pak Ent. 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.

K823058DOSOMETRIC RELEASE STERILIZATIONK820100FROSTED GLASS SLIDESK820099TRACH TAPEK820140WEBRIL CAST PADDINGK820155SPECIALIST CAST PADDINGK820106X-RAY GUAZE SPONGES

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Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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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