510(k) K852054
- Device
- CONTACT LENS LOUPE, INSPETION LOUPE
- Applicant
- ASCON MEDICAL INSTRUMENTS, LTD.
- 510(k) number
- K852054
- Product code
- HLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-05
- Date received
- 1985-05-09
- Regulation
- 886.1420
- Classification name
- Gauge, Lens, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAVI NALLAKRISHNAN
- Address
- 825 N. Cass Ave., Suite 208 Westmont IL US 60559 60559
FDA Registration Numbers#
- 1058726
- 3005785090
- 3017857440
- 8040382
- 3013576617
- 9616250
- 3020386049
- 3012185136
- 3007421138
- 8044098
- 3005211969
- 3004571672
- 3007334784
- 1932180
- 3011137372
- 3013957868
- 3007289540
- 3017970077
- 1045379
- 8040381
- 2434839
- 3014020412
- 3006550126
- 3007774468
- 3021612330
- 3004095901
- 9680718
- 3010041511
- 8040278
- 9617486
- 2529846
- 3011307306
- 3031231776
- 3030451558
- 3004409566
- 3007735390
- 1313525
- 9612075
- 1836161
- 3011110913
- 3008770252
- 3004441848
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K801466 | LEIGH MEASURING SCALE #7725 | Edward Weck, Inc. | 1980-07-28 |
Legacy Summary#
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FDA Review#
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