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FDA 510(k)

I.V. PREP & CARE KIT

K-Number: K771551 · 1977-10-04

ApplicantJelco Laboratories
Decision Date1977-10-04
Product CodeFRL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. PREP & CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1977-10-04 under 510(k) number K771551. The device is classified under product code FRL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V. PREP & CARE KIT?

I.V. PREP & CARE KIT is a medical device that received FDA 510(k) clearance on 1977-10-04. The listed applicant is Jelco Laboratories. The 510(k) number is K771551.

When did I.V. PREP & CARE KIT receive FDA 510(k) clearance?

I.V. PREP & CARE KIT received FDA 510(k) clearance on 1977-10-04, under 510(k) number K771551.

Who is the listed applicant for I.V. PREP & CARE KIT?

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

What is the FDA product code for I.V. PREP & CARE KIT?

The FDA product code for I.V. PREP & CARE KIT is FRL.

Other records listing Jelco Laboratories 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.

K791918JELCO WINGED INTRAVASCULAR CATHETERK791372JELCO & KVO CATHETER PLACEMENT UNITK790967CATHETER METAL HUB/RADIOPAQUEK790968CATHETER METAL HUB/NONRADIOPAQUEK790471JELCO* DISC FILTER-0.2 MICRONK790186PROTECTIVSTABILIZER

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Related Devices (Code: FRL)

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.

K121898STAY FRESH SKIN FOLD MANAGEMENT TEXTILEQuick-Med Technologies, Inc.K110715INTERDRY SILVERMilliken Healthcare Products, LLCK061615INTERDRY TEXTILE WITH SILVERMilliken ChemicalK931626CARAPACE STERILE COTTON BALLSCarapace, Inc.K914081ICAN COTTON RAYON BALLSIcn Pharmaceuticals, Inc.K811990TRACH CLEANING TRAYAssociated Medical Products 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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