Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEPITEL NON-ADHERENT SILICONE DRESSING

K-Number: K914604 · 1992-03-25

ApplicantMolnlycke Clinical Products AB
Decision Date1992-03-25
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEPITEL NON-ADHERENT SILICONE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Clinical Products AB. It received FDA 510(k) clearance on 1992-03-25 under 510(k) number K914604. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEPITEL NON-ADHERENT SILICONE DRESSING?

MEPITEL NON-ADHERENT SILICONE DRESSING is a medical device that received FDA 510(k) clearance on 1992-03-25. The listed applicant is Molnlycke Clinical Products AB. The 510(k) number is K914604.

When did MEPITEL NON-ADHERENT SILICONE DRESSING receive FDA 510(k) clearance?

MEPITEL NON-ADHERENT SILICONE DRESSING received FDA 510(k) clearance on 1992-03-25, under 510(k) number K914604.

Who is the listed applicant for MEPITEL NON-ADHERENT SILICONE DRESSING?

The FDA 510(k) record lists Molnlycke Clinical Products AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEPITEL NON-ADHERENT SILICONE DRESSING?

The FDA product code for MEPITEL NON-ADHERENT SILICONE DRESSING is NAB.

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

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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.

↑