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FDA 510(k)

KERLIX FLUFFS

K-Number: K820053 · 1982-02-04

ApplicantStan-Pak Ent.
Decision Date1982-02-04
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KERLIX FLUFFS 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 1982-02-04 under 510(k) number K820053. 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 KERLIX FLUFFS?

KERLIX FLUFFS is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Stan-Pak Ent.. The 510(k) number is K820053.

When did KERLIX FLUFFS receive FDA 510(k) clearance?

KERLIX FLUFFS received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820053.

Who is the listed applicant for KERLIX FLUFFS?

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 KERLIX FLUFFS?

The FDA product code for KERLIX FLUFFS is NAB.

Related Clinical Trials

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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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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