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FDA 510(k)

SUBDERM TM

K-Number: K853635 · 1985-12-20

ApplicantGeneral Medical Co.
Decision Date1985-12-20
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUBDERM TM is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Co.. It received FDA 510(k) clearance on 1985-12-20 under 510(k) number K853635. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUBDERM TM?

SUBDERM TM is a medical device that received FDA 510(k) clearance on 1985-12-20. The listed applicant is General Medical Co.. The 510(k) number is K853635.

When did SUBDERM TM receive FDA 510(k) clearance?

SUBDERM TM received FDA 510(k) clearance on 1985-12-20, under 510(k) number K853635.

Who is the listed applicant for SUBDERM TM?

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

What is the FDA product code for SUBDERM TM?

The FDA product code for SUBDERM TM is EGJ.

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 General Medical Co. 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.

K926269PROCEDURE KITK912975OPERAND LUBRICATING JELLYK912132OPERAND LUBRICATING JELLYK903669GENESIS INSUFFLATING CATHETERK900110OPERAND* LUBRICATING JELLYK844652C.A.S.E. CONTAINER

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Related Devices (Code: EGJ)

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.

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K241267Hidroxa SE30Hidroxa Medical ABK232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KGK170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development

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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