510(k) K760307

BEDPAN, SINGLE PATIENT USE, TECNOL by Tecnol New Jersey Wound Care, Inc. — Product Code FOB

K760307 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "BEDPAN, SINGLE PATIENT USE, TECNOL". The FDA issued a decision of Substantially Equivalent on August 11, 1976. The device falls under product code FOB (Bedpan), a Class I device regulated under 21 CFR 880.6730. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedpan
Device Class
Class I
Regulation Number
880.6730
Review Panel
HO
Submission Type