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)

SHIELD DISP. PATIENTS PONCHO GOWNS

K-Number: K801570 · 1980-07-28

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1980-07-28
Product CodeFYB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHIELD DISP. PATIENTS PONCHO GOWNS 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 1980-07-28 under 510(k) number K801570. The device is classified under product code FYB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIELD DISP. PATIENTS PONCHO GOWNS?

SHIELD DISP. PATIENTS PONCHO GOWNS is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K801570.

When did SHIELD DISP. PATIENTS PONCHO GOWNS receive FDA 510(k) clearance?

SHIELD DISP. PATIENTS PONCHO GOWNS received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801570.

Who is the listed applicant for SHIELD DISP. PATIENTS PONCHO GOWNS?

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 SHIELD DISP. PATIENTS PONCHO GOWNS?

The FDA product code for SHIELD DISP. PATIENTS PONCHO GOWNS is FYB.

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 SHEETK813419COMFORT CUSHION DRY BURN PAD IIIK813296CONVERTORS STERILE DISP. LAP SPONGE II

View all 19 devices →

Related Devices (Code: FYB)

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.

K911921DISPOSABLE ISOLATION GOWNLiaoning-Usa Corp.K891820DISPOSABLE MEDICAL GOWNSBioshield, Inc.K891053DENTAL BIBDispomed, Inc.K803171PROCEDURE & RECOVERY PATIENT SUITAlba Health CareK771929PEDIATRICS GOWNConvertors

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.

↑