510(k) K911100
K911100 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "MEHIGAN-PILLING PHLEBETOME TM". The FDA issued a decision of Substantially Equivalent on Jun 21, 1991. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Pilling Co. has 39 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 1991
- Date Received
- Mar 12, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Valvulotome
- Device Class
- Class II
- Regulation Number
- 870.4885
- Review Panel
- CV
- Submission Type
- 510(k)