The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Tissue Section Adhesive.
| Device ID | K881659 |
| 510k Number | K881659 |
| Device Name: | TISSUE SECTION ADHESIVE |
| Classification | Gelatin For Specimen Adhesion |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Urban, Ht(ascp) |
| Correspondent | Urban, Ht(ascp) SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | IFZ |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-15 |
| Decision Date | 1988-04-21 |