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FDA 510(k)

MODEL SKCK STERILE KNOB COVER KIT

K-Number: K870662 · 1987-10-28

ApplicantLife-Tech Intl., Inc.
Decision Date1987-10-28
Product CodeBXM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL SKCK STERILE KNOB COVER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1987-10-28 under 510(k) number K870662. The device is classified under product code BXM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL SKCK STERILE KNOB COVER KIT?

MODEL SKCK STERILE KNOB COVER KIT is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K870662.

When did MODEL SKCK STERILE KNOB COVER KIT receive FDA 510(k) clearance?

MODEL SKCK STERILE KNOB COVER KIT received FDA 510(k) clearance on 1987-10-28, under 510(k) number K870662.

Who is the listed applicant for MODEL SKCK STERILE KNOB COVER KIT?

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

What is the FDA product code for MODEL SKCK STERILE KNOB COVER KIT?

The FDA product code for MODEL SKCK STERILE KNOB COVER KIT is BXM.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: BXM)

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.

K013215MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.K002677NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.K921498VER MED A10011 PNS DUAL ELEMENT ELECTRODEVermont Medical, Inc.

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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