510(k) K781264

PAB CONVENIENCE TRAY by Waters Assoc., Inc. — Product Code GAA

K781264 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "PAB CONVENIENCE TRAY". The FDA issued a decision of Substantially Equivalent on September 20, 1978. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1978
Date Received
July 24, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type