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FDA 510(k)

MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P

K-Number: K855031 · 1986-01-21

ApplicantAdvanced Biosearch Assn.
Decision Date1986-01-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K855031. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P?

MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K855031.

When did MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P receive FDA 510(k) clearance?

MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P received FDA 510(k) clearance on 1986-01-21, under 510(k) number K855031.

Who is the listed applicant for MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P?

The FDA 510(k) record lists Advanced Biosearch Assn. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P?

The FDA product code for MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P is HWC. This falls under the Cardiovascular category.

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Other records listing Advanced Biosearch Assn. as applicant

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Related Devices (Code: HWC)

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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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