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FDA 510(k)

HYDROGEL-PREP

K-Number: K791726 · 1979-11-20

ApplicantSpenco Medical Corp.
Decision Date1979-11-20
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDROGEL-PREP is the device name listed in this FDA 510(k) record. The listed applicant is Spenco Medical Corp.. It received FDA 510(k) clearance on 1979-11-20 under 510(k) number K791726. 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 HYDROGEL-PREP?

HYDROGEL-PREP is a medical device that received FDA 510(k) clearance on 1979-11-20. The listed applicant is Spenco Medical Corp.. The 510(k) number is K791726.

When did HYDROGEL-PREP receive FDA 510(k) clearance?

HYDROGEL-PREP received FDA 510(k) clearance on 1979-11-20, under 510(k) number K791726.

Who is the listed applicant for HYDROGEL-PREP?

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

What is the FDA product code for HYDROGEL-PREP?

The FDA product code for HYDROGEL-PREP is NAB.

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Other records listing Spenco Medical 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.

K981902SPENCO SILICONE GEL SHEETK9222282ND SKIN STERILE ADHESIVE STRIPK9115502ND SKIN MOIST BURN PADS WITH ALOEK910927SPENCIO SKIN GUARD KITK896533SPENCO BREAST FORMSK8948982ND SKIN NON-STICK MOIST BURN PADS

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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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