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FDA 510(k)

R1363 PARAFFIN

K-Number: K861346 · 1986-05-02

ApplicantTri W-G, Inc.
Decision Date1986-05-02
Product CodeIMC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

R1363 PARAFFIN is the device name listed in this FDA 510(k) record. The listed applicant is Tri W-G, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861346. The device is classified under product code IMC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R1363 PARAFFIN?

R1363 PARAFFIN is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Tri W-G, Inc.. The 510(k) number is K861346.

When did R1363 PARAFFIN receive FDA 510(k) clearance?

R1363 PARAFFIN received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861346.

Who is the listed applicant for R1363 PARAFFIN?

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

What is the FDA product code for R1363 PARAFFIN?

The FDA product code for R1363 PARAFFIN is IMC.

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Other records listing Tri W-G, 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.

K960196TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777K945163ECHOCARDIOGRAPHYK941720MODEL 747 AND 747-30 EXAM/TREATMENT TABLEK936303TREATMENT TABLE MODIFICATIONK933119HI-LO TREATMENT TABLESK932746MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE

View all 35 devices →

Related Devices (Code: IMC)

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.

K093100REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)Shenzhen Comfort Technology Co., Ltd.K022626MOISTURESTAY (REVLON)Raymond Industrial, Ltd.K013707SOFTIQUE, MODEL GI 11001Global TV Concepts, Ltd.K013328REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600Remington Products Company, LLCK001860PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRAHomedics, Inc.K991427PARAMED PARAFFIN WARMERDivi Intl. Co.

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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