FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HESLIN DISPOS. TUBING SET
K Number: K843041
·
Decision Nov 21, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
12
Review Days
111
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Basic Information
- Device Name
- HESLIN DISPOS. TUBING SET
- K Number
- K843041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Innovative Surgical Products, Inc.
- Date Received
- August 2, 1984
- Decision Date
- November 21, 1984
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Innovative Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K840693 | DISPOSABLE SCLERAL GLOBE PLUG | May 22, 1984 | Substantially Equivalent |
| K840695 | PHACOEMULSIFICATION KITS | May 22, 1984 | Substantially Equivalent |
| K840694 | LENS INSERTION GLIDE | May 9, 1984 | Substantially Equivalent |
| K841072 | IRRIGATION, ASPIRATION TUBING SETS | Mar 29, 1984 | Substantially Equivalent |
| K832235 | DISPOSABLE VITRECTOMY HANDPIECE | Sep 29, 1983 | Substantially Equivalent |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | Jun 22, 1982 | Substantially Equivalent |
| K820765 | PLEURAL DRAINAGE RESERVOIR | Apr 15, 1982 | Substantially Equivalent |
| K820680 | DISPOSABLE TUBING SETS | Apr 9, 1982 | Substantially Equivalent |
| K802973 | ISPVAC TM | Dec 19, 1980 | Substantially Equivalent |
| K801350 | ACUVAC(TM) SUCTION RESERVOIR 400CC AND | Jul 14, 1980 | Substantially Equivalent |