FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESCOTT'S SURGICAL SPEAR
K Number: K003842
·
Decision Apr 13, 2001
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
2
Review Days
122
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Basic Information
- Device Name
- PRESCOTT'S SURGICAL SPEAR
- K Number
- K003842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prescott'S, Inc.
- Date Received
- December 12, 2000
- Decision Date
- April 13, 2001
- Product Code
- HOZ
- 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Prescott'S, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891001 | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE | Apr 11, 1989 | Substantially Equivalent |