Tissue Section Adhesive

FDA 510(k) K881659 · Surgipath Medical Industries, Inc.

Substantially Equivalent

510(k) numberK881659

Submission

Device name
Tissue Section Adhesive
Applicant
Surgipath Medical Industries, Inc.
Grayslake, IL, US
Received
April 15, 1988
Decision date
April 21, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IFZ – Gelatin For Specimen Adhesion
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

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Questions and answers

When was Tissue Section Adhesive cleared by the FDA?

Tissue Section Adhesive (K881659) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 6 days after the submission was received.

What is the product code of K881659?

The FDA product code is IFZ – Gelatin For Specimen Adhesion, a Class I (low risk) device regulated under 21 CFR 864.4010.