510(k) K810558
K810558 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "SKIN SCRUB TRAY". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code HFD (Washer, Endometrial), a Class II device regulated under 21 CFR 884.1185. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1981
- Date Received
- March 2, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1185
- Review Panel
- OB
- Submission Type