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FDA 510(k)

ULTRA-GEL - #4083

K-Number: K864189 · 1986-12-04

ApplicantJohn F. Greer Co., Inc.
Decision Date1986-12-04
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRA-GEL - #4083 is the device name listed in this FDA 510(k) record. The listed applicant is John F. Greer Co., Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K864189. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-GEL - #4083?

ULTRA-GEL - #4083 is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is John F. Greer Co., Inc.. The 510(k) number is K864189.

When did ULTRA-GEL - #4083 receive FDA 510(k) clearance?

ULTRA-GEL - #4083 received FDA 510(k) clearance on 1986-12-04, under 510(k) number K864189.

Who is the listed applicant for ULTRA-GEL - #4083?

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

What is the FDA product code for ULTRA-GEL - #4083?

The FDA product code for ULTRA-GEL - #4083 is EXB.

Related Clinical Trials

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Other records listing John F. Greer Co., 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.

K870577E-Z LOOPK870531EZ TAC FILTERK864190E-Z HOLD - #4060K864188E-Z HOLD WITH ADHESIVE BASE.-#4065

Related Devices (Code: EXB)

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.

K252140Heylo™ SystemColoplast Corp.K181643SmartBag (SmartPouch)11 Health Technologies LimitedK922730LAKE OSTOMY CARE SETLake Medical Products, Inc.K882878ODOR-END EMERGENCY CLEAN UP POWDERCdc Products Corp.K881636CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)Coloplast A/SK880306EMERGENCY-CLEAN UP(TM) ECPCdc Products Corp.

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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