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FDA 510(k)

STEMPLEX

K-Number: K781167 · 1978-09-15

ApplicantRich-Mar Corp.
Decision Date1978-09-15
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STEMPLEX is the device name listed in this FDA 510(k) record. The listed applicant is Rich-Mar Corp.. It received FDA 510(k) clearance on 1978-09-15 under 510(k) number K781167. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEMPLEX?

STEMPLEX is a medical device that received FDA 510(k) clearance on 1978-09-15. The listed applicant is Rich-Mar Corp.. The 510(k) number is K781167.

When did STEMPLEX receive FDA 510(k) clearance?

STEMPLEX received FDA 510(k) clearance on 1978-09-15, under 510(k) number K781167.

Who is the listed applicant for STEMPLEX?

The FDA 510(k) record lists Rich-Mar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEMPLEX?

The FDA product code for STEMPLEX is IPF.

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Other records listing Rich-Mar Corp. 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.

K040679RICH-MAR AUTOPRISM INFRARED LAMPK031018AUTOGEL PADK032941AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICEK021483RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUNDK013770MODIFICATION TO: WINNER ST-2 STIMULATORK013771MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

View all 43 devices →

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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