510(k) K011789
K011789 is an FDA 510(k) premarket notification submitted by Primeline Medical Products, Inc. for the device "PROCEDURE MASKS: PM4-301 AND PM4-304". The FDA issued a decision of Substantially Equivalent on June 22, 2001. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Primeline Medical Products, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2001
- Date Received
- June 8, 2001
- Clearance Type
- Special
- 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