FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ALMORE FACE MASK
K Number: K862851
·
Decision Aug 12, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
14
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Basic Information
- Device Name
- ALMORE FACE MASK
- K Number
- K862851
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Almore Intl., Inc.
- Date Received
- July 29, 1986
- Decision Date
- August 12, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Almore Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854692 | MONARCH II BLEACHING INSTRUMENT | May 12, 1986 | Substantially Equivalent |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Mar 25, 1986 | Substantially Equivalent |
| K854691 | DIAMOND BURS-HANDPIECE | Mar 25, 1986 | Substantially Equivalent |
| K854700 | EZ-ON TUBING CONDITIONER (LUBRICANT) | Mar 12, 1986 | Substantially Equivalent |
| K854702 | PLASTIC MOUNTING RINGS | Mar 6, 1986 | Substantially Equivalent |
| K854701 | RETRACT-A-CORD | Mar 6, 1986 | Substantially Equivalent |
| K854697 | TUBING HANDPIECE REPLACEMENT | Mar 6, 1986 | Substantially Equivalent |
| K854699 | TUBING SYRING | Jan 6, 1986 | Substantially Equivalent |
| K831136 | DOUBLE BOW TOOTH SEPARATOR | Jun 8, 1983 | Substantially Equivalent |