510(k) K861315
K861315 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "HYPERBARIC PENETRATION EXTENSION SET". The FDA issued a decision of Substantially Equivalent on May 21, 1986. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1986
- Date Received
- April 8, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Hyperbaric
- Device Class
- Class II
- Regulation Number
- 868.5470
- Review Panel
- AN
- Submission Type