510(k) K903718
- Device
- Oroscope Model Number Cos-100
- Applicant
- CYGNUS INSTRUMENTS, INC.
- 510(k) number
- K903718
- Product code
- EHZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-09
- Date received
- 1990-08-16
- Regulation
- 872.6640
- Classification name
- Evacuator, Oral Cavity
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- E. M FIRST
- Address
- P.O. Box 60326 Santa Barbara CA US 93160 93160
FDA Registration Numbers#
- 1051614
- 3027234828
- 2029234
- 8020776
- 3003618527
- 2437780
- 1036212
- 3011210208
- 3004046477
- 3004096300
- 3000892153
- 3043648115
- 3009420946
- 1219113
- 3011526299
- 3010864832
- 1651260
- 3010656982
- 3006017180
- 3014345250
- 8030905
- 1066741
- 8040278
- 9616119
- 3007165189
- 1941138
- 3003902312
- 3005004041
- 9611367
- 3004201548
- 3035858919
- 9611503
- 3004727093
- 2133714
- 1921846
- 3003600526
- 1417592
- 3045058049
- 3029780
- 3015703934
- 3003963832
- 2424472
- 3012421607
- 3006210673
- 3003969055
- 3006979803
- 1319130
- 3010162973
- 3005841027
- 3015509619
- 3007515069
- 3004425647
- 3049552730
- 3009219448
- 3033011342
- 2515379
- 3004753334
- 3004538333
- 3008729549
- 3015173212
- 9611827
- 3005554774
- 3002808270
- 3005418651
- 3003877407
- 3038718579
- 1000293143
- 3006008984
- 3011554142
- 3015136927
- 1422507
- 3004519921
- 3044150131
- 3016798774
- 3009893622
- 1000179416
- 3004776555
- 3047906906
- 3017910185
- 3015729
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EHZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973248 | IMTEC BONE COLLECTOR SYSTEM | Imtec Corp. | 1997-11-19 |
| K941164 | TAP EXPRESS EJECTOR | Tap Express, Inc. | 1994-05-18 |
| K911072 | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | A & F Products | 1991-05-15 |
| K892881 | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. | 1989-06-23 |
| K892882 | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. | 1989-06-23 |
| K880754 | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. | 1988-05-12 |
| K873545 | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT | Commercial Products & Engineering Co. | 1987-11-20 |
| K874401 | TITANIUM SUCTION TIP | Implant Innovations International, Inc. | 1987-11-12 |
| K864621 | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. | 1987-02-13 |
| K863769 | EVACUATOR TIPS | The Medical Group, Inc. | 1986-10-30 |
| K801682 | SPACELINE HIGH VOLUME EVACUATION HANDPIE | Pacific Dental Corp. | 1980-08-04 |
| K782068 | MVS UNIT, MODEL SEU-8 AND DEU-8, 80 | Dentsply Intl. | 1979-01-26 |
| K781486 | STERI-VAC POWER UNITS | Cpac, Inc. | 1978-09-27 |
| K781488 | MVS-MODEL SEU-6, DEU-6 | Dentsply Intl. | 1978-09-27 |
| K780701 | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. | 1978-05-16 |