510(k) K012435
- Device
- ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
- Applicant
- BAUSCH & LOMB, INC.
- 510(k) number
- K012435
- Product code
- NGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-02
- Date received
- 2001-07-31
- Regulation
- 886.4350
- Classification name
- Cannula, Trocar, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VANADA JOHNSON
- Address
- 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122
FDA Registration Numbers#
- 3008936260
- 9710524
- 3015456951
- 3003398873
- 1646747
- 1047843
- 1450662
- 2935428
- 9681121
- 2011171
- 1064371
- 3033485955
- 3004475955
- 3008754084
- 1928237
- 3004892425
- 1932402
- 1000614268
- 1920664
- 8040278
- 1644019
- 2523835
- 3012185136
- 3008902714
- 8040233
- 3031231776
- 1057358
- 9611516
- 2531321
- 9710098
- 1424263
- 9615745
- 1319660
- 2028159
- 3012428834
- 1929756
- 3012481881
- 3006550126
- 1650907
- 3013576617
- 2246552
- 3007791573
- 2529846
- 3004467263
- 3003882387
- 3005941719
- 3010208880
- 1000286794
- 1313525
- 3009217531
- 3002991496
- 3010220595
- 3009027787
- 3009337401
- 8043816
- 3002692886
- 9616245
- 3005012805
- 1058726
- 3011110913
Source Documents#
Legacy Summary#
summary
FDA Review#
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