Cleared Traditional

COVERSLIPPER

K780261 · Shandon, Inc. · Hematology

Apr 1978

Decision

61d

Days

Class 1

Risk

About This 510(k) Submission

K780261 is an FDA 510(k) clearance for the COVERSLIPPER, a Device For Sealing Microsections (Class I — General Controls, product code KIM), submitted by Shandon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978, 61 days after receiving the submission on February 16, 1978. This device falls under the Hematology review panel. Regulated under 21 CFR 864.3400.

Submission Details

510(k) Number	K780261 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 1978
Decision Date	April 18, 1978
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—