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FDA 510(k)

SABA-COOMBS MINI EXTERNAL FIXATOR

K-Number: K842343 · 1984-09-11

ApplicantZimmer, Inc.
Decision Date1984-09-11
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SABA-COOMBS MINI EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1984-09-11 under 510(k) number K842343. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABA-COOMBS MINI EXTERNAL FIXATOR?

SABA-COOMBS MINI EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1984-09-11. The listed applicant is Zimmer, Inc.. The 510(k) number is K842343.

When did SABA-COOMBS MINI EXTERNAL FIXATOR receive FDA 510(k) clearance?

SABA-COOMBS MINI EXTERNAL FIXATOR received FDA 510(k) clearance on 1984-09-11, under 510(k) number K842343.

Who is the listed applicant for SABA-COOMBS MINI EXTERNAL FIXATOR?

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

What is the FDA product code for SABA-COOMBS MINI EXTERNAL FIXATOR?

The FDA product code for SABA-COOMBS MINI EXTERNAL FIXATOR is JEC.

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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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