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FDA 510(k)

ISO-CARE KIT

K-Number: K781539 · 1978-11-03

ApplicantNice-Pak Products, Inc.
Decision Date1978-11-03
Product CodeHMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISO-CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nice-Pak Products, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781539. The device is classified under product code HMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISO-CARE KIT?

ISO-CARE KIT is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Nice-Pak Products, Inc.. The 510(k) number is K781539.

When did ISO-CARE KIT receive FDA 510(k) clearance?

ISO-CARE KIT received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781539.

Who is the listed applicant for ISO-CARE KIT?

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

What is the FDA product code for ISO-CARE KIT?

The FDA product code for ISO-CARE KIT is HMP.

Other records listing Nice-Pak Products, 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.

K974768PDI STERILE LUBRICATING JELLYK840343PDI PREPMASTER WET PACK VAGINAL-X21477K840342PDI PREPMASTER WET PACK PATIENT PREP KITK840344PDI PREPMASTER WET PACK MINOR PROCEDUREK833549PDI SURGICAL SCRUB/BRUSH T150-70K810337PDI SURGICAL SCRUB SPONGE-BRUSH-T15070

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Related Devices (Code: HMP)

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.

K940333EYE PADCertified Safety Mfg., Inc.K921349STERILE,DISPOSABLE EYE DRESSINGDeroyal Industries, Inc.K904896EYE PADUlti-Med Intl., Inc.K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309Consolidated Industries of Greater Syracuse, Inc.K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.K864810LIDSPLINTPrecision Therapeutics, 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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