FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL PAC
K Number: K834161
·
Decision Dec 28, 1983
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
9
Review Days
75
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Basic Information
- Device Name
- UNIVERSAL PAC
- K Number
- K834161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Surgical Co., Inc.
- Date Received
- October 14, 1983
- Decision Date
- December 28, 1983
- Product Code
- HQC
- 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | FDA class 2 | Ophthalmic |
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Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+
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Other Clearances by American Surgical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834162 | VIT PAC | Feb 7, 1986 | Substantially Equivalent |
| K834160 | VITREONIC PLUS | Feb 7, 1986 | Substantially Equivalent |
| K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK | Oct 5, 1984 | Substantially Equivalent |
| K834163 | ULTRAVIT | Dec 28, 1983 | Substantially Equivalent |
| K833617 | EXTRA PLUS TM | Dec 28, 1983 | Substantially Equivalent |
| K834158 | EXTRA SENSORY PLUS | Dec 28, 1983 | Substantially Equivalent |
| K833697 | EXTRA SENSORY PAK-DISPOS. ACCESS | Dec 28, 1983 | Substantially Equivalent |
| K834159 | PHACOTRON PLUS | Dec 28, 1983 | Substantially Equivalent |