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FDA 510(k)

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION

K-Number: K911996 · 1991-07-17

ApplicantInternational Technidyne Corp.
Decision Date1991-07-17
Product CodeJCA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K911996. The device is classified under product code JCA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION?

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is International Technidyne Corp.. The 510(k) number is K911996.

When did SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION receive FDA 510(k) clearance?

SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911996.

Who is the listed applicant for SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION?

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

What is the FDA product code for SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION?

The FDA product code for SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION is JCA.

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Related Devices (Code: JCA)

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.

K911745SIMPLATE PEDIATRICOrganon Teknika Corp.K871318Q.I.C. BLEEDING TIME DEVICEHelena LaboratoriesK850542SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.K830645BLEEDING TIME DEVICE DISPOSABLEAmerican DadeK801815AUTOLETUlster Scientific, Inc.K761250SIMPLATEGeneral Diagnostics

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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