510(k) K945117
K945117 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "DELTA". The FDA issued a decision of Substantially Equivalent on February 28, 1997. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1997
- Date Received
- October 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type