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FDA 510(k)

SASMAR ORIGINAL, SASMAR CLASSIC

K-Number: K131084 · 2013-09-13

ApplicantSasmar, Inc.
Decision Date2013-09-13
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SASMAR ORIGINAL, SASMAR CLASSIC is the device name listed in this FDA 510(k) record. The listed applicant is Sasmar, Inc.. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K131084. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SASMAR ORIGINAL, SASMAR CLASSIC?

SASMAR ORIGINAL, SASMAR CLASSIC is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Sasmar, Inc.. The 510(k) number is K131084.

When did SASMAR ORIGINAL, SASMAR CLASSIC receive FDA 510(k) clearance?

SASMAR ORIGINAL, SASMAR CLASSIC received FDA 510(k) clearance on 2013-09-13, under 510(k) number K131084.

Who is the listed applicant for SASMAR ORIGINAL, SASMAR CLASSIC?

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

What is the FDA product code for SASMAR ORIGINAL, SASMAR CLASSIC?

The FDA product code for SASMAR ORIGINAL, SASMAR CLASSIC is NUC.

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 Sasmar, 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.

K131355CONCEIVE PLUS

Related Devices (Code: NUC)

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.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, 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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