FDA 510(k)

STERILE BIOPSY NEEDLES

K-Number: K853559 · 1985-09-11

Decision Date1985-09-11

Product Code

DecisionSubstantially Equivalent

Device Summary

STERILE BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Plasmedics, Inc.. It received FDA 510(k) clearance on 1985-09-11 under 510(k) number K853559. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE BIOPSY NEEDLES?

STERILE BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 1985-09-11. The listed applicant is Plasmedics, Inc.. The 510(k) number is K853559.

When did STERILE BIOPSY NEEDLES receive FDA 510(k) clearance?

STERILE BIOPSY NEEDLES received FDA 510(k) clearance on 1985-09-11, under 510(k) number K853559.

Who is the listed applicant for STERILE BIOPSY NEEDLES?

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

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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.