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)

COMFORT CUSHION DRY BURN PAD III

K-Number: K813419 · 1982-01-22

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1982-01-22
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMFORT CUSHION DRY BURN PAD III is the device name listed in this FDA 510(k) record. The listed applicant is American Convertors Div., American Pharmaseal. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813419. 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 COMFORT CUSHION DRY BURN PAD III?

COMFORT CUSHION DRY BURN PAD III is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K813419.

When did COMFORT CUSHION DRY BURN PAD III receive FDA 510(k) clearance?

COMFORT CUSHION DRY BURN PAD III received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813419.

Who is the listed applicant for COMFORT CUSHION DRY BURN PAD III?

The FDA 510(k) record lists American Convertors Div., American Pharmaseal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT CUSHION DRY BURN PAD III?

The FDA product code for COMFORT CUSHION DRY BURN PAD III 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 American Convertors Div., American Pharmaseal 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.

K840957ANTIMICROBIAL INCISE DRAPEK832137CONVERTORS FLASH STERILIZING TRAYK830786DISIMETRIC RELEASE OF INSTRANETICS RADK820994ABSORB FURN SHEETK813296CONVERTORS STERILE DISP. LAP SPONGE IIK813078CONTURA DISPOS. SURG. FACE MASK

View all 19 devices →

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.

↑