FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
K Number: K002849
·
Decision Oct 18, 2000
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
22
Review Days
35
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Basic Information
- Device Name
- PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
- K Number
- K002849
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Specialties Corp
- Date Received
- September 13, 2000
- Decision Date
- October 18, 2000
- Product Code
- HNO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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| K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL | Aug 6, 2007 | Substantially Equivalent |
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| K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES | May 9, 2007 | Substantially Equivalent |
| K053380 | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE | Jan 18, 2006 | Substantially Equivalent |
| K052962 | OPTIMIZED BARB DESIGN | Dec 6, 2005 | Substantially Equivalent |