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FDA 510(k)

PROCEDURE & RECOVERY PATIENT SUIT

K-Number: K803171 · 1981-03-04

ApplicantAlba Health Care
Decision Date1981-03-04
Product CodeFYB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROCEDURE & RECOVERY PATIENT SUIT is the device name listed in this FDA 510(k) record. The listed applicant is Alba Health Care. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K803171. 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 PROCEDURE & RECOVERY PATIENT SUIT?

PROCEDURE & RECOVERY PATIENT SUIT is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Alba Health Care. The 510(k) number is K803171.

When did PROCEDURE & RECOVERY PATIENT SUIT receive FDA 510(k) clearance?

PROCEDURE & RECOVERY PATIENT SUIT received FDA 510(k) clearance on 1981-03-04, under 510(k) number K803171.

Who is the listed applicant for PROCEDURE & RECOVERY PATIENT SUIT?

The FDA 510(k) record lists Alba Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROCEDURE & RECOVERY PATIENT SUIT?

The FDA product code for PROCEDURE & RECOVERY PATIENT SUIT is FYB.

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Other records listing Alba Health Care 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.

K864689ALBA HEALTH CARE IODOFORM PACKING STRIPK861154ALBA HEALTH CARE PLAIN PACKING STRIPK851918INFANT PHOTOTHERAPY MASKK850904ALBA DRY BURN DRESSINGK850881ALBA DRY BURN PADK850241ALBA HEALTH CARE NON-ADHERING DRESSING

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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.K801570SHIELD DISP. PATIENTS PONCHO GOWNSAmerican Convertors Div., American PharmasealK771929PEDIATRICS 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.

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