510(k) K882315
K882315 is an FDA 510(k) premarket notification submitted by Viratec Corp. for the device "VIR-A-VAC EMPTY". The FDA issued a decision of Substantially Equivalent on September 26, 1988. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1988
- Date Received
- June 3, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type