510(k) K872233
K872233 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "INJECT-EASE". The FDA issued a decision of Substantially Equivalent on Sep 4, 1987. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Palco Laboratories, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 4, 1987
- Date Received
- Jun 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Introducer, Syringe Needle
- Device Class
- Class II
- Regulation Number
- 880.6920
- Review Panel
- HO
- Submission Type
- 510(k)