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FDA 510(k)

ORCEPAD

K-Number: K875123 · 1988-06-21

ApplicantAlton Dean Medical, Inc.
Decision Date1988-06-21
Product CodeHDD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORCEPAD is the device name listed in this FDA 510(k) record. The listed applicant is Alton Dean Medical, Inc.. It received FDA 510(k) clearance on 1988-06-21 under 510(k) number K875123. The device is classified under product code HDD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORCEPAD?

ORCEPAD is a medical device that received FDA 510(k) clearance on 1988-06-21. The listed applicant is Alton Dean Medical, Inc.. The 510(k) number is K875123.

When did ORCEPAD receive FDA 510(k) clearance?

ORCEPAD received FDA 510(k) clearance on 1988-06-21, under 510(k) number K875123.

Who is the listed applicant for ORCEPAD?

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

What is the FDA product code for ORCEPAD?

The FDA product code for ORCEPAD is HDD.

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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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