510(k) K811990
K811990 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "TRACH CLEANING TRAY". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1981
- Date Received
- July 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fiber, Medical, Absorbent
- Device Class
- Class I
- Regulation Number
- 880.5300
- Review Panel
- HO
- Submission Type