510(k) K950633
- Device
- CANDELA URETHRAL/BLADDER SOUND
- Applicant
- CANDELA LASER CORP.
- 510(k) number
- K950633
- Product code
- FBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-06
- Date received
- 1995-02-13
- Regulation
- 876.5520
- Classification name
- Sound, Urethral, Metal Or Plastic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS R VARRICCHIONE
- Address
- 530 Boston Post Rd. Wayland MA US 01778 01778
FDA Registration Numbers#
- 1651252
- 9614075
- 8030607
- 8010099
- 3004608878
- 9611590
- 9680304
- 9611252
- 9612278
- 1421879
- 1123010
- 1720747
- 3006554912
- 3005809810
- 3012267976
- 9613079
- 3011137372
- 3009632672
- 3009703496
- 1018233
- 9611283
- 3008936260
- 9710058
- 1421101
- 2434839
- 9611827
- 9680718
- 2529846
- 3004215117
- 3012507533
- 3010041511
- 3003418325
- 8040278
- 9710524
- 9610621
- 3005440795
- 9611112
- 3006553489
- 3007137643
- 1836161
- 1923569
- 9610612
- 8040233
- 3014334038
- 3004001706
- 3001644167
- 3015895045
- 3008770252
- 1320468
- 2916714
- 8040172
- 2431166
- 3006082230
- 3009513193
Source Documents#
Legacy Summary#
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FDA Review#
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