FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
K Number: K895479
·
Decision Mar 9, 1990
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
21
Applicant Total
15
Review Days
179
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Basic Information
- Device Name
- THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
- K Number
- K895479
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5995
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Thayer Medical Corp.
- Date Received
- September 11, 1989
- Decision Date
- March 9, 1990
- Product Code
- BYH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | FDA class 1 | Anesthesiology |
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Other Clearances by Thayer Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K993101 | LITEAIRE | Oct 26, 2000 | Substantially Equivalent |
| K992722 | PRIMEAIRE | Nov 10, 1999 | Substantially Equivalent |
| K972237 | HAND HELD MEDISPACER | Jul 31, 1997 | Substantially Equivalent |
| K955805 | DUAL SPRAY MINISPACER | Mar 21, 1996 | Substantially Equivalent |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Aug 18, 1994 | Substantially Equivalent |
| K924535 | THAYER HAND HELD M.K.I. HOLDING CHAMBER | Mar 10, 1993 | Substantially Equivalent |
| K914283 | THAYER EXPANSION CHAMBER METERED DOSE INHALER | Feb 26, 1992 | Substantially Equivalent |
| K904917 | THAYER MIP ADAPTER | Jan 28, 1991 | Substantially Equivalent |
| K901739 | THAYER METERED DOSE INHALER DISPENSER/ADAPTER | Oct 9, 1990 | Substantially Equivalent |