510(k) K891178

TECNOL SECURE-ALL TUBE HOLDER by Tecnol New Jersey Wound Care, Inc. — Product Code EYZ

K891178 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL SECURE-ALL TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on May 23, 1989. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
March 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type