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FDA 510(k)

SENSUA!

K-Number: K021125 · 2002-10-25

ApplicantAac Consulting Group, Inc.
Decision Date2002-10-25
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SENSUA! is the device name listed in this FDA 510(k) record. The listed applicant is Aac Consulting Group, Inc.. It received FDA 510(k) clearance on 2002-10-25 under 510(k) number K021125. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSUA!?

SENSUA! is a medical device that received FDA 510(k) clearance on 2002-10-25. The listed applicant is Aac Consulting Group, Inc.. The 510(k) number is K021125.

When did SENSUA! receive FDA 510(k) clearance?

SENSUA! received FDA 510(k) clearance on 2002-10-25, under 510(k) number K021125.

Who is the listed applicant for SENSUA!?

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

What is the FDA product code for SENSUA!?

The FDA product code for SENSUA! is HIS.

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 Aac Consulting Group, 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.

K991469AWARE PAD

Related Devices (Code: HIS)

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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., 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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