FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOREX SAFE-AIR
K Number: K911150
·
Decision Jun 28, 1991
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
105
Basic Information
- Device Name
- SOREX SAFE-AIR
- K Number
- K911150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- SOREX MEDICAL
- Date Received
- March 15, 1991
- Decision Date
- June 28, 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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Other Clearances by SOREX MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K923843 | FOGLESS | Mar 25, 1994 | Substantially Equivalent |
| K913036 | PLUME MASTER | Sep 6, 1991 | Substantially Equivalent |
| K911070 | PICC-FIX | Jul 5, 1991 | Substantially Equivalent |
| K910315 | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K | Apr 5, 1991 | Unknown |
| K905572 | EDLICH WOUND MANAGEMENT TRAY | Mar 12, 1991 | Unknown |
| K903740 | TRACH-EZE | Dec 6, 1990 | Substantially Equivalent |
| K902410 | MEDICAL PROCEDURE TRAY | Nov 20, 1990 | Unknown |
| K885136 | GRAFT GUARD | Feb 6, 1989 | Substantially Equivalent |