510(k) K914086
K914086 is an FDA 510(k) premarket notification submitted by Icn Pharmaceuticals, Inc. for the device "ICAN CYLINDRICAL SPONGES". The FDA issued a decision of Substantially Equivalent on October 9, 1991. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Icn Pharmaceuticals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1991
- Date Received
- September 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scalpel, One-Piece
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type