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FDA 510(k)

GELLHORN PESSARY 33410 VARIOUS SIZES

K-Number: K890565 · 1989-03-29

ApplicantMedi-Source, Inc.
Decision Date1989-03-29
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GELLHORN PESSARY 33410 VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Source, Inc.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K890565. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELLHORN PESSARY 33410 VARIOUS SIZES?

GELLHORN PESSARY 33410 VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Medi-Source, Inc.. The 510(k) number is K890565.

When did GELLHORN PESSARY 33410 VARIOUS SIZES receive FDA 510(k) clearance?

GELLHORN PESSARY 33410 VARIOUS SIZES received FDA 510(k) clearance on 1989-03-29, under 510(k) number K890565.

Who is the listed applicant for GELLHORN PESSARY 33410 VARIOUS SIZES?

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

What is the FDA product code for GELLHORN PESSARY 33410 VARIOUS SIZES?

The FDA product code for GELLHORN PESSARY 33410 VARIOUS SIZES is HHW.

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Other records listing Medi-Source, 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.

K903402GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026LK890566BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZESK890567BITE BLOCK #59430

Related Devices (Code: HHW)

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.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, 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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