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FDA 510(k)

HYDRAGEL CSF ISOFOCUSING KITS

K-Number: K033277 · 2003-11-04

ApplicantMorax
Decision Date2003-11-04
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL CSF ISOFOCUSING KITS is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 2003-11-04 under 510(k) number K033277. 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 CSF ISOFOCUSING KITS?

HYDRAGEL CSF ISOFOCUSING KITS is a medical device that received FDA 510(k) clearance on 2003-11-04. The listed applicant is Morax. The 510(k) number is K033277.

When did HYDRAGEL CSF ISOFOCUSING KITS receive FDA 510(k) clearance?

HYDRAGEL CSF ISOFOCUSING KITS received FDA 510(k) clearance on 2003-11-04, under 510(k) number K033277.

Who is the listed applicant for HYDRAGEL CSF ISOFOCUSING 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 CSF ISOFOCUSING KITS?

The FDA product code for HYDRAGEL CSF ISOFOCUSING KITS is CFF.

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Other records listing Morax 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.

K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KITK991362HYDRAGEL 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 0K981048HYDRAGEL 6 CSF KITK974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

View all 12 devices →

Related Devices (Code: CFF)

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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.

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