FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
YANKAUER SUCTION DEVICE
K Number: K905478
·
Decision Dec 19, 1990
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
31
Review Days
13
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Basic Information
- Device Name
- YANKAUER SUCTION DEVICE
- K Number
- K905478
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medovations, Inc.
- Date Received
- December 6, 1990
- Decision Date
- December 19, 1990
- Product Code
- MDM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
| K142068 | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE | Mar 10, 2015 | Substantially Equivalent |
| K002363 | MEDOVATIONS ESOPHAGEAL DILATOR | Nov 1, 2000 | Substantially Equivalent |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Feb 2, 1998 | Substantially Equivalent |
| K924646 | OVER THE GUIDEWIRE DILATATION SYSTEM | Dec 5, 1994 | Substantially Equivalent |
| K913678 | TROCAR CATHETER | Dec 16, 1991 | Substantially Equivalent |
| K874309 | URETHAL CATHETER | Dec 7, 1987 | Substantially Equivalent |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Oct 14, 1987 | Substantially Equivalent |
| K864962 | OBERTO MOUTH PROP | Feb 19, 1987 | Substantially Equivalent |
| K864964 | 5 - IN - 1 CONNECTOR | Jan 20, 1987 | Substantially Equivalent |
| K854616 | ENTERAL FEEDING BAG | Jan 23, 1986 | Substantially Equivalent |