510(k) K771908
K771908 is an FDA 510(k) premarket notification submitted by 3M Company for the device "ISO-SHIELD SALIVA ABSORBERS". The FDA issued a decision of Substantially Equivalent on November 7, 1977. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1977
- Date Received
- October 11, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorber, Saliva, Paper
- Device Class
- Class I
- Regulation Number
- 872.6050
- Review Panel
- DE
- Submission Type