FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
K Number: K883705
·
Decision Nov 14, 1988
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
7
Review Days
76
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Basic Information
- Device Name
- FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS
- K Number
- K883705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Select Sources, Inc.
- Date Received
- August 30, 1988
- Decision Date
- November 14, 1988
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
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Other Clearances by Select Sources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884328 | CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE) | Apr 26, 1989 | Substantially Equivalent |
| K883078 | INSULIN SYRINGE | Oct 31, 1988 | Substantially Equivalent |
| K883033 | PISTON SYRINGE WITH NEEDLE | Oct 31, 1988 | Substantially Equivalent |
| K880919 | (CHOICE) ALSO (KONDUM) | Jun 29, 1988 | Substantially Equivalent |
| K864482 | CHOICE | Dec 22, 1986 | Substantially Equivalent |
| K863190 | CHOICE CONDOM | Dec 3, 1986 | Substantially Equivalent |