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FDA 510(k)

MULTIPLE SCRUB SUIT

K-Number: K822483 · 1982-09-17

ApplicantSurgilite Intl., Inc.
Decision Date1982-09-17
Product CodeFXO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIPLE SCRUB SUIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgilite Intl., Inc.. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822483. The device is classified under product code FXO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE SCRUB SUIT?

MULTIPLE SCRUB SUIT is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Surgilite Intl., Inc.. The 510(k) number is K822483.

When did MULTIPLE SCRUB SUIT receive FDA 510(k) clearance?

MULTIPLE SCRUB SUIT received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822483.

Who is the listed applicant for MULTIPLE SCRUB SUIT?

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

What is the FDA product code for MULTIPLE SCRUB SUIT?

The FDA product code for MULTIPLE SCRUB SUIT is FXO.

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.

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Other records listing Surgilite Intl., 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.

K823671NO-GAUZE LAPAROTOMY SPONGEK822482SURGILITE NON-WOVEN WRAPK822481MULTIPLE SURGICAL MASKK771531LAPAROTOMY SPONGES

Related Devices (Code: FXO)

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.

K914615BTP(TM) CENTRALINE(TM) SUITBtp Industries, Inc.K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPEPro-Safe Professional Linens, Inc.K882282SUIT, SURGICALA Plus International, Inc.K865022SURGICAL GARMENTSUlti-Med Intl., Inc.K831207SPUNGUARD SCRUB SUITKimberly-Clark Corp.

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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