510(k) K914615
K914615 is an FDA 510(k) premarket notification submitted by Btp Industries, Inc. for the device "BTP(TM) CENTRALINE(TM) SUIT". The FDA issued a decision of Substantially Equivalent on May 5, 1992. The device falls under product code FXO (Suit, Surgical), a Class I device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1992
- Date Received
- October 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suit, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type