510(k) K873830

TECNOL SURGEON'S CAP by Tecnol New Jersey Wound Care, Inc. — Product Code FYF

K873830 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL SURGEON'S CAP". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
September 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
Submission Type