510(k) K852345
K852345 is an FDA 510(k) premarket notification submitted by Safety Sea Systems, Inc. for the device "SEA-LONG NECKSEAL & HOOD". The FDA issued a decision of Substantially Equivalent on June 20, 1985. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1985
- Date Received
- May 31, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tent, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5700
- Review Panel
- AN
- Submission Type