The following data is part of a premarket notification filed by Medical Technology Development Corp. with the FDA for Instrument Sterilization Tray.
Device ID | K863726 |
510k Number | K863726 |
Device Name: | INSTRUMENT STERILIZATION TRAY |
Classification | Tray, Surgical, Instrument |
Applicant | MEDICAL TECHNOLOGY DEVELOPMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
Contact | Jose H Bedoya |
Correspondent | Jose H Bedoya MEDICAL TECHNOLOGY DEVELOPMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-23 |
Decision Date | 1986-10-14 |