FDA 510(k)

SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT

K-Number: K870518 · 1987-04-29

Decision Date1987-04-29

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1987-04-29 under 510(k) number K870518. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT?

SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT is a medical device that received FDA 510(k) clearance on 1987-04-29. The listed applicant is Surgitek. The 510(k) number is K870518.

When did SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT receive FDA 510(k) clearance?

SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT received FDA 510(k) clearance on 1987-04-29, under 510(k) number K870518.

Who is the listed applicant for SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT?

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

What is the FDA product code for SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT?

The FDA product code for SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT is FMF.

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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.