510(k) K810284
K810284 is an FDA 510(k) premarket notification submitted by R. Wolf Medical Instruments Corp. for the device "AUTOMATIC TEFLON INJECTION SYRINGE". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code KCP (Syringe, Ent), a Class I device regulated under 21 CFR 874.5220. R. Wolf Medical Instruments Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1981
- Date Received
- February 2, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Ent
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type