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FDA 510(k)

BUONAFEDE PNEUMATIC SLEEVE

K-Number: K954201 · 1995-11-09

ApplicantPromedic, Inc.
Decision Date1995-11-09
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BUONAFEDE PNEUMATIC SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K954201. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUONAFEDE PNEUMATIC SLEEVE?

BUONAFEDE PNEUMATIC SLEEVE is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Promedic, Inc.. The 510(k) number is K954201.

When did BUONAFEDE PNEUMATIC SLEEVE receive FDA 510(k) clearance?

BUONAFEDE PNEUMATIC SLEEVE received FDA 510(k) clearance on 1995-11-09, under 510(k) number K954201.

Who is the listed applicant for BUONAFEDE PNEUMATIC SLEEVE?

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

What is the FDA product code for BUONAFEDE PNEUMATIC SLEEVE?

The FDA product code for BUONAFEDE PNEUMATIC SLEEVE is KCY.

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Other records listing Promedic, 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.

K112318CLEARPATH 24K072756NON-IV ADAPTER FOR INFANT NG TUBEK060497BABYAIRK060842REVJET TURBOK052903PEDIATRIC FEEDING TUBEK031409URINARY CATHETERS

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Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, 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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