The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Modified Shiley Low Pressure Cuffed Tracheo. Tubes.
Device ID | K880247 |
510k Number | K880247 |
Device Name: | MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES |
Classification | Tube, Tracheostomy (w/wo Connector) |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Ganz Pobuda |
Correspondent | Ganz Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Product Code | BTO |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-20 |
Decision Date | 1988-02-12 |