510(k) K760750
K760750 is an FDA 510(k) premarket notification submitted by Dennison Manufacturing Co. for the device "STERILE TUBULAR UNBLEACHED STOCKINETTE". The FDA issued a decision of Substantially Equivalent on October 8, 1976. The device falls under product code JLG (Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids), a Class I device regulated under 21 CFR 862.1290.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1976
- Date Received
- October 1, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
- Device Class
- Class I
- Regulation Number
- 862.1290
- Review Panel
- CH
- Submission Type