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)

DERMA-AID

K-Number: K820198 · 1982-03-05

ApplicantWinfield Laboratories, Inc.
Decision Date1982-03-05
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA-AID is the device name listed in this FDA 510(k) record. The listed applicant is Winfield Laboratories, Inc.. It received FDA 510(k) clearance on 1982-03-05 under 510(k) number K820198. 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 DERMA-AID?

DERMA-AID is a medical device that received FDA 510(k) clearance on 1982-03-05. The listed applicant is Winfield Laboratories, Inc.. The 510(k) number is K820198.

When did DERMA-AID receive FDA 510(k) clearance?

DERMA-AID received FDA 510(k) clearance on 1982-03-05, under 510(k) number K820198.

Who is the listed applicant for DERMA-AID?

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

What is the FDA product code for DERMA-AID?

The FDA product code for DERMA-AID 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

Other records listing Winfield Laboratories, 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.

K973538N-TERFACEK923602ABSORBENT PAD -- MODIFICATIONK872069KONTOUR ULTRA SOFT SPONGE #SS144.50

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.

↑