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FDA 510(k)

PRECISE

K-Number: K970827 · 1997-04-16

ApplicantAllan Schulman,D.D.S., M.S.
Decision Date1997-04-16
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRECISE is the device name listed in this FDA 510(k) record. The listed applicant is Allan Schulman,D.D.S., M.S.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K970827. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISE?

PRECISE is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Allan Schulman,D.D.S., M.S.. The 510(k) number is K970827.

When did PRECISE receive FDA 510(k) clearance?

PRECISE received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970827.

Who is the listed applicant for PRECISE?

The FDA 510(k) record lists Allan Schulman,D.D.S., M.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISE?

The FDA product code for PRECISE is EJH.

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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.

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