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FDA 510(k)

DISPOSABLE, STERILE BIOPSY PUNCH

K-Number: K853104 · 1985-10-04

ApplicantAugust C. Stiefel Research Institute, Inc.
Decision Date1985-10-04
Product CodeFCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, STERILE BIOPSY PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is August C. Stiefel Research Institute, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853104. The device is classified under product code FCI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE, STERILE BIOPSY PUNCH?

DISPOSABLE, STERILE BIOPSY PUNCH is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is August C. Stiefel Research Institute, Inc.. The 510(k) number is K853104.

When did DISPOSABLE, STERILE BIOPSY PUNCH receive FDA 510(k) clearance?

DISPOSABLE, STERILE BIOPSY PUNCH received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853104.

Who is the listed applicant for DISPOSABLE, STERILE BIOPSY PUNCH?

The FDA 510(k) record lists August C. Stiefel Research Institute, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE, STERILE BIOPSY PUNCH?

The FDA product code for DISPOSABLE, STERILE BIOPSY PUNCH is FCI.

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Related Devices (Code: FCI)

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.

K895885AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTINGNational-Standard Co.K894627BT-338N ELECTRONIC CLINICAL THERMOMETERIntegrated Display Technology, Ltd.K875119BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBEAdvanced Diagnostic Medical Systems, Inc.K831317BIOPSY ATTACHMENTDiasonics, Inc.

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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