FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO MODEL 90-1460 LASER ADAPTER
K Number: K911523
·
Decision Apr 22, 1991
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
23
Review Days
18
Basic Information
- Device Name
- MODIFICATION TO MODEL 90-1460 LASER ADAPTER
- K Number
- K911523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- LIFESTREAM INT'L, INC.
- Date Received
- April 4, 1991
- Decision Date
- April 22, 1991
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
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| K920618 | AUTOTRANSFUSION SUCTION SET | Mar 12, 1993 | Substantially Equivalent |
| K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM | May 20, 1992 | Substantially Equivalent |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | Dec 23, 1991 | Substantially Equivalent |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | Oct 31, 1991 | Substantially Equivalent |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | Mar 29, 1991 | Substantially Equivalent |
| K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 | Feb 1, 1991 | Substantially Equivalent |
| K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH | Oct 26, 1990 | Substantially Equivalent |