The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Cassette Embosseer.
Device ID | K863483 |
510k Number | K863483 |
Device Name: | CASSETTE EMBOSSEER |
Classification | Cassettes, Tissue |
Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Contact | Urban, Ht |
Correspondent | Urban, Ht SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Product Code | IDZ |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-09 |
Decision Date | 1986-09-16 |