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FDA 510(k)

SOF. PRESS EPC 51 SYSTEM

K-Number: K963067 · 1997-01-28

ApplicantGaymar Industries, Inc.
Decision Date1997-01-28
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOF. PRESS EPC 51 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1997-01-28 under 510(k) number K963067. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF. PRESS EPC 51 SYSTEM?

SOF. PRESS EPC 51 SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-28. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K963067.

When did SOF. PRESS EPC 51 SYSTEM receive FDA 510(k) clearance?

SOF. PRESS EPC 51 SYSTEM received FDA 510(k) clearance on 1997-01-28, under 510(k) number K963067.

Who is the listed applicant for SOF. PRESS EPC 51 SYSTEM?

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

What is the FDA product code for SOF. PRESS EPC 51 SYSTEM?

The FDA product code for SOF. PRESS EPC 51 SYSTEM is JOW.

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Other records listing Gaymar Industries, Inc. as applicant

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Related Devices (Code: JOW)

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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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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