FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDICRAFT INFANT REFLUX WEDGE
K Number: K905629
·
Decision Mar 13, 1991
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
13
Applicant Total
5
Review Days
89
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Basic Information
- Device Name
- PEDICRAFT INFANT REFLUX WEDGE
- K Number
- K905629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5680
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pedicraft, Inc.
- Date Received
- December 14, 1990
- Decision Date
- March 13, 1991
- Product Code
- FRP
- 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 |
|---|---|---|---|
| FRP | Holder, Infant Position | FDA class 1 | General Hospital |
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Other Clearances by Pedicraft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925949 | PEDICRAGT BASSINET | Apr 20, 1993 | Substantially Equivalent |
| K925817 | HEAD & FOOT END DROP PEDI-CRIB | Apr 20, 1993 | Substantially Equivalent |
| K905630 | INFANT REFLUX SLING | Mar 13, 1991 | Substantially Equivalent |
| K821773 | PEDICRAFT BED, MODEL B2944 | Jun 23, 1982 | Substantially Equivalent |