510(k) K935998
K935998 is an FDA 510(k) premarket notification submitted by Camp Intl., Inc. for the device "ENTERPRISE". The FDA issued a decision of Substantially Equivalent on November 17, 1995. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Camp Intl., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1995
- Date Received
- December 15, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type