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FDA 510(k)

DOUBLE SEAL TUBEGUAZE STERILE BANDAGE

K-Number: K813308 · 1981-12-29

ApplicantScholl, Inc.
Decision Date1981-12-29
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DOUBLE SEAL TUBEGUAZE STERILE BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Scholl, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813308. 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 DOUBLE SEAL TUBEGUAZE STERILE BANDAGE?

DOUBLE SEAL TUBEGUAZE STERILE BANDAGE is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Scholl, Inc.. The 510(k) number is K813308.

When did DOUBLE SEAL TUBEGUAZE STERILE BANDAGE receive FDA 510(k) clearance?

DOUBLE SEAL TUBEGUAZE STERILE BANDAGE received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813308.

Who is the listed applicant for DOUBLE SEAL TUBEGUAZE STERILE BANDAGE?

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

What is the FDA product code for DOUBLE SEAL TUBEGUAZE STERILE BANDAGE?

The FDA product code for DOUBLE SEAL TUBEGUAZE STERILE BANDAGE is NAB.

Related Clinical Trials

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Other records listing Scholl, Inc. 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.

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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

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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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