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FDA 510(k)

IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK

K-Number: K971473 · 1997-07-07

ApplicantM-Pact Worldwide Management Corp.
Decision Date1997-07-07
Product CodeGEC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is M-Pact Worldwide Management Corp.. It received FDA 510(k) clearance on 1997-07-07 under 510(k) number K971473. The device is classified under product code GEC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK?

IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK is a medical device that received FDA 510(k) clearance on 1997-07-07. The listed applicant is M-Pact Worldwide Management Corp.. The 510(k) number is K971473.

When did IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK receive FDA 510(k) clearance?

IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK received FDA 510(k) clearance on 1997-07-07, under 510(k) number K971473.

Who is the listed applicant for IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK?

The FDA 510(k) record lists M-Pact Worldwide Management Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK?

The FDA product code for IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK is GEC.

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 M-Pact Worldwide Management Corp. 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.

K971832IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICKK964113IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL

Related Devices (Code: GEC)

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.

K960621EXPANDACELL INSTRUMENT WIPEShippert Medical Technologies Corp.K900691BIODYNE INSTRUMENT WIPESBio-Dyne, Inc.K896085SURGI-BRUSHSparta Surgical Corp.K875033STERILE SCRUBBY SCRUB BRUSHMedsurg Industries, Inc.K875129STERI-CLENSAbsorbent Cotton Co., Inc.K872823DELTA SCRUBPacific Biosystems, Inc.

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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