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FDA 510(k)

SPENCO CRYOPRESS

K-Number: K820906 · 1982-05-13

ApplicantSpenco Medical Corp.
Decision Date1982-05-13
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPENCO CRYOPRESS 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 1982-05-13 under 510(k) number K820906. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPENCO CRYOPRESS?

SPENCO CRYOPRESS is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Spenco Medical Corp.. The 510(k) number is K820906.

When did SPENCO CRYOPRESS receive FDA 510(k) clearance?

SPENCO CRYOPRESS received FDA 510(k) clearance on 1982-05-13, under 510(k) number K820906.

Who is the listed applicant for SPENCO CRYOPRESS?

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 SPENCO CRYOPRESS?

The FDA product code for SPENCO CRYOPRESS is IMD.

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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: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, 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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