FDA 510(k)

HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS

K-Number: K960669 · 1996-07-12

ApplicantMorax

Decision Date1996-07-12

Product CodeCFF

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1996-07-12 under 510(k) number K960669. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS?

HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS is a medical device that received FDA 510(k) clearance on 1996-07-12. The listed applicant is Morax. The 510(k) number is K960669.

When did HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS receive FDA 510(k) clearance?

HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS received FDA 510(k) clearance on 1996-07-12, under 510(k) number K960669.

Who is the listed applicant for HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS?

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 IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS?

The FDA product code for HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS is CFF.

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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 K974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

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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.