FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
K Number: K883839
·
Decision Dec 9, 1988
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
3
Applicant Total
28
Review Days
88
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Basic Information
- Device Name
- ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
- K Number
- K883839
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Marlo Surgical Technology
- Date Received
- September 12, 1988
- Decision Date
- December 9, 1988
- Product Code
- KYP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KYP | Snake Bite Suction Kit | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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| K Number | Device Name | ||
|---|---|---|---|
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| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Jul 31, 1996 | Substantially Equivalent |
| K924611 | IRRIGATION PUMP AND TUBING SET | Jun 30, 1994 | Substantially Equivalent |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | Feb 25, 1994 | Substantially Equivalent |
| K932832 | PRIMUS INSULATED FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K920611 | MARLOW LAPAROSCOPIC GRASPING FORCEP | Apr 20, 1993 | Substantially Equivalent |
| K914153 | OTT INSUFFLATOR FILTER PLUS/TUBING SET | Apr 2, 1992 | Substantially Equivalent |
| K914869 | MARLOW LAPAROSCOPIC SCISSORS | Jan 15, 1992 | Substantially Equivalent |
| K913954 | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS | Dec 18, 1991 | Substantially Equivalent |
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | Nov 19, 1991 | Substantially Equivalent |