FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHARMASEAL EYE PREP TRAY
K Number: K850119
·
Decision May 9, 1985
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
64
Review Days
115
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Basic Information
- Device Name
- PHARMASEAL EYE PREP TRAY
- K Number
- K850119
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- January 14, 1985
- Decision Date
- May 9, 1985
- Product Code
- HNR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by American Pharmaseal Div. Ahsc
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|---|---|---|---|
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| K871429 | ANTIMICROBIAL FOLEY CATHETER | Aug 10, 1987 | Substantially Equivalent |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | May 8, 1987 | Substantially Equivalent |
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