510(k) K875008
K875008 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "GUARDALL SHIELD". The FDA issued a decision of Substantially Equivalent on March 11, 1988. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Anago, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1988
- Date Received
- December 4, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type