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FDA 510(k)

DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO

K-Number: K982096 · 1999-06-18

ApplicantRapid Mfg. Co.
Decision Date1999-06-18
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Mfg. Co.. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K982096. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO?

DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Rapid Mfg. Co.. The 510(k) number is K982096.

When did DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO receive FDA 510(k) clearance?

DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO received FDA 510(k) clearance on 1999-06-18, under 510(k) number K982096.

Who is the listed applicant for DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO?

The FDA 510(k) record lists Rapid Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO?

The FDA product code for DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO is GXY.

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Official Source

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