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FDA 510(k)

ROBINSON KIT - 750014 & 750016

K-Number: K772342 · 1978-02-24

ApplicantLatex Ind., Inc.
Decision Date1978-02-24
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROBINSON KIT - 750014 & 750016 is the device name listed in this FDA 510(k) record. The listed applicant is Latex Ind., Inc.. It received FDA 510(k) clearance on 1978-02-24 under 510(k) number K772342. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROBINSON KIT - 750014 & 750016?

ROBINSON KIT - 750014 & 750016 is a medical device that received FDA 510(k) clearance on 1978-02-24. The listed applicant is Latex Ind., Inc.. The 510(k) number is K772342.

When did ROBINSON KIT - 750014 & 750016 receive FDA 510(k) clearance?

ROBINSON KIT - 750014 & 750016 received FDA 510(k) clearance on 1978-02-24, under 510(k) number K772342.

Who is the listed applicant for ROBINSON KIT - 750014 & 750016?

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

What is the FDA product code for ROBINSON KIT - 750014 & 750016?

The FDA product code for ROBINSON KIT - 750014 & 750016 is FCM.

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Other records listing Latex Ind., 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.

K812058AKRON URINARY DRAINAGE BATK810281UROLOGICAL CATHETERSK791674BLADDER RETENTION CATHETERIZATION TRAYK781751CATHETER, AKRON FOLEY TEFLONK781433AKRON MALE EXTERNAL CATHETERK772277BLADDER RETENTION-CATHETHERIZATIONTRAY

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Related Devices (Code: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.

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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