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FDA 510(k)

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE

K-Number: K935643 · 1994-06-10

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1994-06-10
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K935643. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE?

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K935643.

When did SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE receive FDA 510(k) clearance?

SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE received FDA 510(k) clearance on 1994-06-10, under 510(k) number K935643.

Who is the listed applicant for SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE?

The FDA 510(k) record lists Regulatory & Marketing Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE?

The FDA product code for SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE is KNY.

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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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