510(k) K843468
- Device
- PHARMA-PLAST SUCTION SET TYPE YANKAUER
- Applicant
- ZIMMAR CONSULTING LTD.
- 510(k) number
- K843468
- Product code
- GEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-23
- Date received
- 1984-09-06
- Regulation
- 878.4800
- Classification name
- Cannula, Surgical, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3019696820
- 1423537
- 3013576619
- 1000632857
- 9614093
- 3005809810
- 3016248634
- 3008110533
- 1421101
- 3015895045
- 9680741
- 1054241
- 2245304
- 3010097171
- 3003696170
- 3011706110
- 8010273
- 1032347
- 3017567825
- 1220477
- 3010455030
- 3030979014
- 9611274
- 3015289316
- 3010273872
- 8043507
- 3016467822
- 3017102971
- 3009417901
- 3042235752
- 3007597038
- 3008797953
- 1036836
- 2126670
- 2084346
- 1820334
- 3003828812
- 3006142527
- 1822565
- 8043971
- 1417485
- 9612030
- 3005440795
- 1017768
- 3006694268
- 2134285
- 1828464
- 3004513872
- 9611610
- 3003431869
- 3004215117
- 3008102049
- 3034688516
- 2210968
- 3029082594
- 3004705187
- 1054811
- 3001408183
- 1030489
- 3005528784
- 1424263
- 2434839
- 3004423487
- 3008559295
- 1051526
- 8010099
- 1317547
- 8040233
- 2249529
- 2032809
- 3004464325
- 9614062
- 3006561161
- 3007791599
- 3008902714
- 9613926
- 3007441485
- 3023155873
- 3007137643
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003965 | MRI SAFE INSTRUMENTS | Aesculap, Inc. | 2001-03-16 |
| K982472 | GENICON TROCAR | Genicon, LC | 1999-02-04 |
| K954599 | CONMED TROGARD ELECTRONIC TROCAR SYSTEM | Conmedcorp | 1995-11-27 |
| K922460 | ORIGIN SECONDARY CANNULA AND TROCAR | Origin Medsystems, Inc. | 1992-09-16 |
| K920110 | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | ETHICON, Inc. | 1992-04-02 |
| K911262 | DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER | ETHICON, Inc. | 1991-06-20 |
| K904881 | DISPOSABLE YANKAUER SUCTION TUBE | Pilling Medical S.A. | 1991-03-06 |
| K903416 | CANNULA, SURGICAL | Advantage Diagnostics Corp. | 1990-11-23 |
| K904218 | SUCTION SYSTEM | Axiom Medical, Inc. | 1990-10-31 |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| K901717 | KLEIN MICRO-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | Jeff Klein Surgical, Inc. | 1990-05-22 |
| K895684 | SOFT SUCTION ADAPTER | Applied Medical Technologies | 1989-11-20 |
| K896434 | AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* | United States Surgical, A Division of Tyco Healthc | 1989-11-16 |
| K895762 | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC | Kolster Methods | 1989-10-18 |
Legacy Summary#
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FDA Review#
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