FDA 510(k)

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

K-Number: K974854 · 1998-10-07

ApplicantMorax

Decision Date1998-10-07

Product CodeJHO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K974854. The device is classified under product code JHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207?

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Morax. The 510(k) number is K974854.

When did HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 receive FDA 510(k) clearance?

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 received FDA 510(k) clearance on 1998-10-07, under 510(k) number K974854.

Who is the listed applicant for HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207?

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

What is the FDA product code for HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207?

The FDA product code for HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 is JHO.

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Other records listing Morax as applicant

K033277HYDRAGEL CSF ISOFOCUSING KITS K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT K991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 K981048HYDRAGEL 6 CSF KIT

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Related Devices (Code: JHO)

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena Laboratories K022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134Sebia K013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123Morax K013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena Laboratories K010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix 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.