510(k) K914779
K914779 is an FDA 510(k) premarket notification submitted by Adri/Technam for the device "ALGINATE FIBER". The FDA issued a decision of Substantially Equivalent on December 4, 1991. The device falls under product code NAC (Dressing, Wound, Hydrophilic), a Class I device regulated under 21 CFR 878.4018. Adri/Technam has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1991
- Date Received
- October 23, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Hydrophilic
- Device Class
- Class I
- Regulation Number
- 878.4018
- Review Panel
- SU
- Submission Type