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FDA 510(k)

SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP

K-Number: K800511 · 1980-04-16

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1980-04-16
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP 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 1980-04-16 under 510(k) number K800511. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP?

SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K800511.

When did SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP receive FDA 510(k) clearance?

SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800511.

Who is the listed applicant for SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP?

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 LUCKY CAP; BLOSSOM BOUFFANT CAP?

The FDA product code for SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP is FYF.

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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

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Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, 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.

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