510(k) K834536
K834536 is an FDA 510(k) premarket notification submitted by Warne Surgical Products, Ltd. for the device "CRYSTALCONE FACE MASK-MED-W/HOOKRING". The FDA issued a decision of Substantially Equivalent on January 25, 1984. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Warne Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 1984
- Date Received
- December 22, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Gas, Anesthetic
- Device Class
- Class I
- Regulation Number
- 868.5550
- Review Panel
- AN
- Submission Type