510(k) K781264
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