510(k) K980783
K980783 is an FDA 510(k) premarket notification submitted by Irt Management Corp. for the device "SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5". The FDA issued a decision of Substantially Equivalent on April 21, 1998. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. Irt Management Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1998
- Date Received
- March 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorber, Saliva, Paper
- Device Class
- Class I
- Regulation Number
- 872.6050
- Review Panel
- DE
- Submission Type