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FDA 510(k)

MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK

K-Number: K981073 · 1998-05-15

ApplicantMedcom Laundry Service, Inc.
Decision Date1998-05-15
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Medcom Laundry Service, Inc.. It received FDA 510(k) clearance on 1998-05-15 under 510(k) number K981073. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK?

MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK is a medical device that received FDA 510(k) clearance on 1998-05-15. The listed applicant is Medcom Laundry Service, Inc.. The 510(k) number is K981073.

When did MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK receive FDA 510(k) clearance?

MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK received FDA 510(k) clearance on 1998-05-15, under 510(k) number K981073.

Who is the listed applicant for MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK?

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

What is the FDA product code for MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK?

The FDA product code for MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK is FYA.

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Related Devices (Code: FYA)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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