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FDA 510(k)

TS1 TURTLE(TM) SYRINGE

K-Number: K936225 · 1995-05-16

ApplicantKershenstine Diamond, Inc.
Decision Date1995-05-16
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TS1 TURTLE(TM) SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Kershenstine Diamond, Inc.. It received FDA 510(k) clearance on 1995-05-16 under 510(k) number K936225. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TS1 TURTLE(TM) SYRINGE?

TS1 TURTLE(TM) SYRINGE is a medical device that received FDA 510(k) clearance on 1995-05-16. The listed applicant is Kershenstine Diamond, Inc.. The 510(k) number is K936225.

When did TS1 TURTLE(TM) SYRINGE receive FDA 510(k) clearance?

TS1 TURTLE(TM) SYRINGE received FDA 510(k) clearance on 1995-05-16, under 510(k) number K936225.

Who is the listed applicant for TS1 TURTLE(TM) SYRINGE?

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

What is the FDA product code for TS1 TURTLE(TM) SYRINGE?

The FDA product code for TS1 TURTLE(TM) SYRINGE is MEG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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