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FDA 510(k)

RABINOWITZ GUM MASSAGER

K-Number: K862635 · 1986-09-25

ApplicantArnell, Inc.
Decision Date1986-09-25
Product CodeJEW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RABINOWITZ GUM MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Arnell, Inc.. It received FDA 510(k) clearance on 1986-09-25 under 510(k) number K862635. The device is classified under product code JEW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RABINOWITZ GUM MASSAGER?

RABINOWITZ GUM MASSAGER is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Arnell, Inc.. The 510(k) number is K862635.

When did RABINOWITZ GUM MASSAGER receive FDA 510(k) clearance?

RABINOWITZ GUM MASSAGER received FDA 510(k) clearance on 1986-09-25, under 510(k) number K862635.

Who is the listed applicant for RABINOWITZ GUM MASSAGER?

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

What is the FDA product code for RABINOWITZ GUM MASSAGER?

The FDA product code for RABINOWITZ GUM MASSAGER is JEW.

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Related Devices (Code: JEW)

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.

K843406CHEW-DENTSenair-MotK790588ASSAY REAGENTS, LSA 290Kallestad Laboratories, 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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