510(k) K871478
K871478 is an FDA 510(k) premarket notification submitted by Procedure Pak, Inc. for the device "SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS". The FDA issued a decision of Substantially Equivalent on May 7, 1987. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Procedure Pak, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1987
- Date Received
- April 14, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type