510(k) K870941

PHARMASEAL WOUND CARE DRESSING PAD by American Pharmaseal Div. Ahsc — Product Code KOZ

K870941 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL WOUND CARE DRESSING PAD". The FDA issued a decision of Substantially Equivalent on March 27, 1987. The device falls under product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption), a Class I device regulated under 21 CFR 878.4018. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1987
Date Received
March 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Beads, Hydrophilic, For Wound Exudate Absorption
Device Class
Class I
Regulation Number
878.4018
Review Panel
SU
Submission Type