510(k) K853153
K853153 is an FDA 510(k) premarket notification submitted by Corkes Medical Co. for the device "MEDUS GMBH". The FDA issued a decision of Substantially Equivalent on August 7, 1985. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1985
- Date Received
- July 29, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type