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FDA 510(k)

INGLAT-O-BALL

K-Number: K904774 · 1990-12-07

ApplicantMilex Products, Inc.
Decision Date1990-12-07
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INGLAT-O-BALL is the device name listed in this FDA 510(k) record. The listed applicant is Milex Products, Inc.. It received FDA 510(k) clearance on 1990-12-07 under 510(k) number K904774. 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 INGLAT-O-BALL?

INGLAT-O-BALL is a medical device that received FDA 510(k) clearance on 1990-12-07. The listed applicant is Milex Products, Inc.. The 510(k) number is K904774.

When did INGLAT-O-BALL receive FDA 510(k) clearance?

INGLAT-O-BALL received FDA 510(k) clearance on 1990-12-07, under 510(k) number K904774.

Who is the listed applicant for INGLAT-O-BALL?

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

What is the FDA product code for INGLAT-O-BALL?

The FDA product code for INGLAT-O-BALL is HHW.

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Other records listing Milex Products, 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.

K001545PIPET CURETK904026INFLAT-O-BALLK900903KOPANS HOOKWIRE LESION LOCALIZATION NEEDLEK882628ENDO C BRUSHK862410MILEX KEGEL PERINEAL EXERCISERK861385MILEX BARTHOLIN GLAND CATHETER

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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

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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