FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECEIVING BLANKET
K Number: K904274
·
Decision Oct 26, 1990
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
44
Review Days
38
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Basic Information
- Device Name
- RECEIVING BLANKET
- K Number
- K904274
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Anago, Inc.
- Date Received
- September 18, 1990
- Decision Date
- October 26, 1990
- Product Code
- KME
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KME), ordered by most recent decision date.
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FOIL BABY BUNTING
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Other Clearances by Anago, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925659 | U.C.E.Z. LENS CLEANER KIT | Sep 17, 1993 | Substantially Equivalent |
| K930161 | ANAGO SPINAL ANESTHESIA TRAY | Jul 6, 1993 | Unknown |
| K926589 | ANAGO WARM PACK | May 26, 1993 | Substantially Equivalent |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | May 26, 1993 | Substantially Equivalent |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | May 26, 1993 | Substantially Equivalent |
| K920615 | ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT | Mar 20, 1993 | Unknown |
| K915415 | GUARDALL SHIELD | Oct 15, 1992 | Substantially Equivalent |
| K913558 | RELIABLE CONE STYLE FACE MASK | Nov 7, 1991 | Substantially Equivalent |
| K905865 | ANTI-FOR SURGICAL FACE MASK | Mar 6, 1991 | Substantially Equivalent |
| K905749 | SURGICAL FACE MASK | Mar 4, 1991 | Substantially Equivalent |