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FDA 510(k)

CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)

K-Number: K861198 · 1986-05-16

ApplicantQuali-Med, Inc.
Decision Date1986-05-16
Product Code
DecisionUnknown

Device Summary

CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) is the device name listed in this FDA 510(k) record. The listed applicant is Quali-Med, Inc.. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K861198. FDA Decision: Unknown.

Frequently Asked Questions

What is the CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)?

CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Quali-Med, Inc.. The 510(k) number is K861198.

When did CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) receive FDA 510(k) clearance?

CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861198.

Who is the listed applicant for CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)?

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

Related Clinical Trials

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.

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Other records listing Quali-Med, 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.

K871408BLOOD VESSEL CONNECTORK862972DISPOSABLE MIRRORK862472QUARTZ RODS TITANIUM RODSK862241STANDARD BASIN KIT CUSTOM BASIN KITK862242PAP SMEAR KITK862172QUALI-MED'S OPERATING ROOM DRAPES

View all 7 devices →

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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