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FDA 510(k)

SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC

K-Number: K070117 · 2007-08-06

ApplicantDolomite Biotech Sdn Bhd
Decision Date2007-08-06
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC is the device name listed in this FDA 510(k) record. The listed applicant is Dolomite Biotech Sdn Bhd. It received FDA 510(k) clearance on 2007-08-06 under 510(k) number K070117. 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 SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC?

SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC is a medical device that received FDA 510(k) clearance on 2007-08-06. The listed applicant is Dolomite Biotech Sdn Bhd. The 510(k) number is K070117.

When did SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC receive FDA 510(k) clearance?

SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC received FDA 510(k) clearance on 2007-08-06, under 510(k) number K070117.

Who is the listed applicant for SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC?

The FDA 510(k) record lists Dolomite Biotech Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC?

The FDA product code for SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC 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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