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FDA 510(k)

MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE

K-Number: K885171 · 1989-01-12

ApplicantAndover Medical, Inc.
Decision Date1989-01-12
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Andover Medical, Inc.. It received FDA 510(k) clearance on 1989-01-12 under 510(k) number K885171. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE?

MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE is a medical device that received FDA 510(k) clearance on 1989-01-12. The listed applicant is Andover Medical, Inc.. The 510(k) number is K885171.

When did MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE receive FDA 510(k) clearance?

MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE received FDA 510(k) clearance on 1989-01-12, under 510(k) number K885171.

Who is the listed applicant for MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE?

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

What is the FDA product code for MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE?

The FDA product code for MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE is DRO.

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Other records listing Andover Medical, Inc. as applicant

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Related Devices (Code: DRO)

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K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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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