The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Venesection Tray, Adult 6050.
Device ID | K843627 |
510k Number | K843627 |
Device Name: | VENESECTION TRAY, ADULT 6050 |
Classification | Tray, Surgical, Instrument |
Applicant | PRO-LAB, INC. P.O. BOX 503 Round Rock, TX 78664 |
Contact | Dan Mcdonald |
Correspondent | Dan Mcdonald PRO-LAB, INC. P.O. BOX 503 Round Rock, TX 78664 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-14 |
Decision Date | 1984-12-04 |