510(k) K874161
K874161 is an FDA 510(k) premarket notification submitted by K. W. Griffen Co. for the device "MODIFIED USE OF TRIANGLE BANDAGE STERILE". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. K. W. Griffen Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1987
- Date Received
- October 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Occlusive
- Device Class
- Class I
- Regulation Number
- 878.4020
- Review Panel
- SU
- Submission Type