510(k) K901715
K901715 is an FDA 510(k) premarket notification submitted by Jeff Klein Surgical, Inc. for the device "KLEIN CORK(TM)". The FDA issued a decision of Substantially Equivalent on May 11, 1990. The device falls under product code GCE (Adaptor, Catheter), a Class I device regulated under 21 CFR 878.4200. Jeff Klein Surgical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1990
- Date Received
- April 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Catheter
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type