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FDA 510(k)

SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM

K-Number: K942526 · 1994-07-19

ApplicantLife Medical Sciences, Inc.
Decision Date1994-07-19
Product CodeMKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Medical Sciences, Inc.. It received FDA 510(k) clearance on 1994-07-19 under 510(k) number K942526. The device is classified under product code MKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM?

SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-19. The listed applicant is Life Medical Sciences, Inc.. The 510(k) number is K942526.

When did SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM receive FDA 510(k) clearance?

SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM received FDA 510(k) clearance on 1994-07-19, under 510(k) number K942526.

Who is the listed applicant for SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM?

The FDA 510(k) record lists Life Medical Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM?

The FDA product code for SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM is MKY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life Medical Sciences, Inc. 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.

K980563SKAR-KARE SHEETK926127SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM

Related Devices (Code: MKY)

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.

K002315WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.

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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