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FDA 510(k)

SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD

K-Number: K965187 · 1997-08-01

ApplicantSparta Surgical Corp.
Decision Date1997-08-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD is the device name listed in this FDA 510(k) record. The listed applicant is Sparta Surgical Corp.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K965187. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD?

SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Sparta Surgical Corp.. The 510(k) number is K965187.

When did SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD receive FDA 510(k) clearance?

SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD received FDA 510(k) clearance on 1997-08-01, under 510(k) number K965187.

Who is the listed applicant for SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD?

The FDA 510(k) record lists Sparta Surgical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD?

The FDA product code for SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD is GZJ.

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Other records listing Sparta Surgical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945313SPARTA HYDROGEL WOUND DRESSINGK922729SPARTA WET DRESSING, SODIUM CHLORIDEK905384DAVID SIMMONDS ANESTHESIA EXTENSION TUBESK905240VESSELOOPSK896085SURGI-BRUSHK896084MICROSPEARS

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Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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