510(k) K851675
K851675 is an FDA 510(k) premarket notification submitted by Lingeman Medical Products, Inc. for the device "THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE". The FDA issued a decision of Substantially Equivalent on May 14, 1985. The device falls under product code EYY (Drape, Urological, Disposable), a Class II device regulated under 21 CFR 878.4370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1985
- Date Received
- April 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Urological, Disposable
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type