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FDA 510(k)

DRESSING SPONGE

K-Number: K822987 · 1982-11-05

ApplicantHermitage Hospital Products, Inc.
Decision Date1982-11-05
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRESSING SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Hermitage Hospital Products, Inc.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K822987. 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 DRESSING SPONGE?

DRESSING SPONGE is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Hermitage Hospital Products, Inc.. The 510(k) number is K822987.

When did DRESSING SPONGE receive FDA 510(k) clearance?

DRESSING SPONGE received FDA 510(k) clearance on 1982-11-05, under 510(k) number K822987.

Who is the listed applicant for DRESSING SPONGE?

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

What is the FDA product code for DRESSING SPONGE?

The FDA product code for DRESSING SPONGE is NAB.

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Other records listing Hermitage Hospital Products, 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.

K941802OR TOWELK923115CLINISORBK923116COMBINE II WETPROOF PADK891324HERMITEX SPONGEK863737SPONGES STERILE TWIN PAKT AND SINGLESK843788CUSTOM BURN DRESSING KIT

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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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