Cleared Traditional

K770970 - HAIR TRANSPLANT PUNCH, MULTIPLH
(FDA 510(k) Clearance)

K770970 · Padgett Instruments, Inc. · General & Plastic Surgery device

Oct 1977

Decision

149d

Days

Class 1

Risk

K770970 is an FDA 510(k) clearance for the HAIR TRANSPLANT PUNCH, MULTIPLH. This device is classified as a Stylet, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAH).

Submitted by Padgett Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1977, 149 days after receiving the submission on May 31, 1977.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K770970 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 1977
Decision Date	October 27, 1977
Days to Decision	149 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—