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FDA 510(k)

ENTERIC-TEK

K-Number: K792058 · 1980-01-11

ApplicantFlow Laboratories, Inc.
Decision Date1980-01-11
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTERIC-TEK is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1980-01-11 under 510(k) number K792058. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERIC-TEK?

ENTERIC-TEK is a medical device that received FDA 510(k) clearance on 1980-01-11. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K792058.

When did ENTERIC-TEK receive FDA 510(k) clearance?

ENTERIC-TEK received FDA 510(k) clearance on 1980-01-11, under 510(k) number K792058.

Who is the listed applicant for ENTERIC-TEK?

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

What is the FDA product code for ENTERIC-TEK?

The FDA product code for ENTERIC-TEK is JSS.

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Other records listing Flow Laboratories, Inc. as applicant

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Related Devices (Code: JSS)

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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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