FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OPTHALAS PHOTOCOAGULATOR
K Number: K828585
·
Decision Jan 3, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- OPTHALAS PHOTOCOAGULATOR
- K Number
- K828585
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Synemed, Inc.
- Date Received
- November 23, 1982
- Decision Date
- January 3, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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|---|---|---|---|
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| K833274 | DERMATOLOGY HANDPIECE-OPHTH LASER | Dec 3, 1983 | Substantially Equivalent |
| K831085 | SYNEVAC VACUUM SOURCE UNIT | Jun 8, 1983 | Substantially Equivalent |
| K822853 | MODEL 200 SQUID | Oct 18, 1982 | Substantially Equivalent |
| K813282 | SYNEVAC VACUUM CURETTAGE SYSTEMS | Dec 14, 1981 | Substantially Equivalent |
| K811270 | SCOPE MASTER | Sep 8, 1981 | Substantially Equivalent |