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FDA 510(k)

SPIRAL

K-Number: K920514 · 1994-02-22

ApplicantThornton Associates, Inc.
Decision Date1994-02-22
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPIRAL is the device name listed in this FDA 510(k) record. The listed applicant is Thornton Associates, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K920514. 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 SPIRAL?

SPIRAL is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Thornton Associates, Inc.. The 510(k) number is K920514.

When did SPIRAL receive FDA 510(k) clearance?

SPIRAL received FDA 510(k) clearance on 1994-02-22, under 510(k) number K920514.

Who is the listed applicant for SPIRAL?

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

What is the FDA product code for SPIRAL?

The FDA product code for SPIRAL 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 Thornton Associates, 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.

K852238IPG-300

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

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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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