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FDA 510(k)

SANISERV SURGICAL SLUSH SYSTEM

K-Number: K894006 · 1989-11-03

ApplicantSaniserv, Inc.
Decision Date1989-11-03
Product CodeJRM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANISERV SURGICAL SLUSH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Saniserv, Inc.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K894006. The device is classified under product code JRM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANISERV SURGICAL SLUSH SYSTEM?

SANISERV SURGICAL SLUSH SYSTEM is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Saniserv, Inc.. The 510(k) number is K894006.

When did SANISERV SURGICAL SLUSH SYSTEM receive FDA 510(k) clearance?

SANISERV SURGICAL SLUSH SYSTEM received FDA 510(k) clearance on 1989-11-03, under 510(k) number K894006.

Who is the listed applicant for SANISERV SURGICAL SLUSH SYSTEM?

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

What is the FDA product code for SANISERV SURGICAL SLUSH SYSTEM?

The FDA product code for SANISERV SURGICAL SLUSH SYSTEM is JRM.

Related Clinical Trials

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Related Devices (Code: JRM)

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.

K921569ORS-200Mnlase, Inc.K921570ORS-300Mnlase, Inc.K921568ORS-100Mnlase, Inc.K915427ORS-1000Mnlase, Inc.K913777SELF-CONTAINED SURGICAL SLUSH FREEZERTaylor Corp.K782077LANCER ICE CUBESherwood Medical Industries

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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