510(k) K883984
K883984 is an FDA 510(k) premarket notification submitted by Bio-Dyne, Inc. for the device "HEMORX COLD PACK". The FDA issued a decision of Substantially Equivalent on Dec 22, 1988. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. Bio-Dyne, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 1988
- Date Received
- Sep 20, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Thermal, Hemorrhoids
- Device Class
- Class U
- Review Panel
- GU
- Submission Type
- 510(k)