510(k) K964111
- Device
- LITHOVAC SUCTION/ASPIRATION PROBE
- Applicant
- ELECTRO MEDICAL SYSTEMS SA
- 510(k) number
- K964111
- Product code
- KQT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-12-16
- Date received
- 1996-10-15
- Regulation
- 876.4370
- Classification name
- Evacuator, Gastro-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY MCNAMARA-CULLINANE
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3017565103
- 3028977843
- 2648623
- 1825146
- 3006673317
- 2649614
- 1018233
- 3030516433
- 2431166
- 9610617
- 3009104075
- 1526711
- 3010202439
- 1649518
- 3009746061
- 1450997
- 9611102
- 2020550
- 9617744
- 1423662
- 1648564
- 3010041511
- 3008837339
- 8030987
- 3005099803
- 3005987240
- 3011050570
- 3014342096
- 3004096429
- 1424263
- 3033848208
- 1828132
- 9611590
- 1000121056
- 3006082230
- 1820334
- 8010877
- 9680718
- 8010418
- 3017590240
- 3012494290
- 2936485
- 9611503
- 1528319
- 3015895045
- 1222612
- 2124215
- 2953359
- 3006174295
- 3004365956
- 2085947
- 1519132
- 1937141
- 3003790304
Source Documents#
Other 510(k) Records For Product Code KQT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921088 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | 1992-10-28 |
| K921451 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | 1992-10-28 |
| K910728 | CLEANFLOW SYSTEM | Mitron Technologies, Inc. | 1991-04-01 |
| K880099 | VAN-TEC BLADDER EVACUATOR | Van-Tec, Inc. | 1988-03-02 |
| K874493 | BELLA - VAC IRRIGATOR | Bel-Can Industries | 1988-02-05 |
| K860266 | ELLIK EVACUATOR | R. J. Ltd., Ind. | 1986-03-05 |
| K830546 | DOSIMETRIC RELEASE | American Hospital Supply Corp. | 1983-05-25 |
| K811779 | ROSS-EMERSON PUMP, MODEL 55-R | J. H. Emerson Co. | 1981-07-13 |
| K810739 | SUCTION WOUND DRAINAGE DEVICE | The Urology Group | 1981-06-26 |
| K801781 | CATHETER IRRIGATION SYRINGES, #3100,3110 | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| K801782 | GENERAL PURPOSE IRRIGATING/ASPIR SYR. | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| K800397 | ELLIK BLADDER EVACUATOR | Sage Products, Inc. | 1980-03-10 |
| K791306 | ELLIK EVACUATOR | Davol, Inc. | 1979-08-03 |
Legacy Summary#
summary
FDA Review#
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