FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REPL. PISTON FOR TROUTMAN CORNEAL PUNCH
K Number: K791988
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
2
Applicant Total
140
Review Days
35
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Basic Information
- Device Name
- REPL. PISTON FOR TROUTMAN CORNEAL PUNCH
- K Number
- K791988
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- September 25, 1979
- Decision Date
- October 30, 1979
- Product Code
- HNJ
- 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 |
|---|---|---|---|
| HNJ | Punch, Corneo-Scleral | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNJ), ordered by most recent decision date.
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DORC CORNEAL PUNCH BLOCK
FDA 510(k)
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| K914470 | PNEUMO-SEAL(TM) | Nov 29, 1991 | Substantially Equivalent |
| K911272 | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | Jul 2, 1991 | Substantially Equivalent |
| K902108 | HEM-O-LOK(TM) | Aug 6, 1990 | Substantially Equivalent |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | Aug 2, 1990 | Substantially Equivalent |
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | Feb 15, 1990 | Substantially Equivalent |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | Aug 27, 1987 | Substantially Equivalent |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | Jul 2, 1985 | Substantially Equivalent |