FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HERSHMAN LENS FORCEPS WITH IRRIGATOR
K Number: K770097
·
Decision Jan 24, 1977
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
140
Review Days
7
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Basic Information
- Device Name
- HERSHMAN LENS FORCEPS WITH IRRIGATOR
- K Number
- K770097
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- January 17, 1977
- Decision Date
- January 24, 1977
- 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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| K902108 | HEM-O-LOK(TM) | Aug 6, 1990 | Substantially Equivalent |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | Aug 2, 1990 | Substantially Equivalent |
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| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | Aug 27, 1987 | Substantially Equivalent |
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