510(k) K864688
K864688 is an FDA 510(k) premarket notification submitted by Angiosystems, Inc. for the device "ARNOLD-KING PRESSURE DRESSING". The FDA issued a decision of Substantially Equivalent on January 12, 1987. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Angiosystems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1987
- Date Received
- December 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Occlusive
- Device Class
- Class I
- Regulation Number
- 878.4020
- Review Panel
- SU
- Submission Type