FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000
K Number: K863754
·
Decision Oct 17, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
4
Review Days
22
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Basic Information
- Device Name
- FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000
- K Number
- K863754
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Foundations Plus, Inc.
- Date Received
- September 25, 1986
- Decision Date
- October 17, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Foundations Plus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871138 | FOUNDATIONS PLUS ABDOMINAL BAND 1100 | Apr 23, 1987 | Substantially Equivalent for Some Indications |
| K864477 | FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000 | Dec 2, 1986 | Substantially Equivalent |
| K863753 | FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 | Oct 30, 1986 | Substantially Equivalent |