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FDA 510(k)

HEMSTATS

K-Number: K844152 · 1984-11-07

ApplicantI M, Inc.
Decision Date1984-11-07
Product CodeHRQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEMSTATS is the device name listed in this FDA 510(k) record. The listed applicant is I M, Inc.. It received FDA 510(k) clearance on 1984-11-07 under 510(k) number K844152. The device is classified under product code HRQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMSTATS?

HEMSTATS is a medical device that received FDA 510(k) clearance on 1984-11-07. The listed applicant is I M, Inc.. The 510(k) number is K844152.

When did HEMSTATS receive FDA 510(k) clearance?

HEMSTATS received FDA 510(k) clearance on 1984-11-07, under 510(k) number K844152.

Who is the listed applicant for HEMSTATS?

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

What is the FDA product code for HEMSTATS?

The FDA product code for HEMSTATS is HRQ.

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Other records listing I M, 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.

K914600NEUROLOGICAL SPONGEK892389BIOPSY KITK881363SYRINGE PREFILLED WITH WATERK880753UMBILICAL CORD CLAMPK872741NUTRIPUMPK871495BANDAGES CATALOG NUMBER: 101 TO 220

View all 41 devices →

Related Devices (Code: HRQ)

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.

K920298DISPOSABLE HEMOSTATSFalcon Instruments, Inc.K895683BERNARD VESSEL APPROXIMATORApplied Medical TechnologiesK890245SURGICAL HEMOSTATSKinetic Medical ProductsK884196SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)Disposable Sterile Surgical Instruments, Inc.K881937SURGICAL INSTRUMENTSFar East Intl. Trading Corp.K861807MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)Medcomp Technologies, 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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