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FDA 510(k)

DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS

K-Number: K961087 · 1996-05-16

ApplicantDebusk Knitting Mills, Div. Deroyal Industries
Decision Date1996-05-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS is the device name listed in this FDA 510(k) record. The listed applicant is Debusk Knitting Mills, Div. Deroyal Industries. It received FDA 510(k) clearance on 1996-05-16 under 510(k) number K961087. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS?

DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Debusk Knitting Mills, Div. Deroyal Industries. The 510(k) number is K961087.

When did DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS receive FDA 510(k) clearance?

DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS received FDA 510(k) clearance on 1996-05-16, under 510(k) number K961087.

Who is the listed applicant for DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS?

The FDA 510(k) record lists Debusk Knitting Mills, Div. Deroyal Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS?

The FDA product code for DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS is GEI.

Related Clinical Trials

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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Other records listing Debusk Knitting Mills, Div. Deroyal Industries 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.

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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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