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FDA 510(k)

PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.

K-Number: K882654 · 1988-09-20

ApplicantSurgical Innovators of America, Inc.
Decision Date1988-09-20
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovators of America, Inc.. It received FDA 510(k) clearance on 1988-09-20 under 510(k) number K882654. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.?

PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. is a medical device that received FDA 510(k) clearance on 1988-09-20. The listed applicant is Surgical Innovators of America, Inc.. The 510(k) number is K882654.

When did PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. receive FDA 510(k) clearance?

PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. received FDA 510(k) clearance on 1988-09-20, under 510(k) number K882654.

Who is the listed applicant for PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.?

The FDA 510(k) record lists Surgical Innovators of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.?

The FDA product code for PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. is GEY.

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Related Devices (Code: GEY)

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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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