510(k) K810627
- Device
- MODEL 1301 BIOTAC (TM)
- Applicant
- PROGRESS MANKIND TECHNOLOGY
- 510(k) number
- K810627
- Product code
- GEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-02
- Date received
- 1981-03-09
- 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#
- Contact
- Alfred A Iversen
- Address
- Box 464 Hopkins MN US 55343 55343
FDA Registration Numbers#
- 3006561161
- 3015859709
- 3034688516
- 1222773
- 1226544
- 1833986
- 1721504
- 3003687489
- 1320894
- 3001297506
- 3008843439
- 3010611926
- 3015398570
- 1221934
- 3008559295
- 3005528784
- 9615005
- 3022568093
- 3004705187
- 9614062
- 3012447612
- 3004361445
- 3001408183
- 2248030
- 8043385
- 3007289408
- 3015895045
- 2183456
- 3023138850
- 1649660
- 3015289316
- 3042235752
- 3018094310
- 1000614268
- 1043214
- 1061927
- 3010455030
- 1058020
- 3010052499
- 3006638824
- 3012452798
- 3007441485
- 3003587189
- 1645452
- 3012724179
- 8043496
- 3010726901
- 1720929
- 3005405146
- 2084346
- 9610773
- 3006847937
- 1423662
- 2529846
- 3014656668
- 1424478
- 3014437893
- 3010026090
- 1313525
- 9611274
- 1527736
- 3006128100
- 3007366790
- 1828464
- 3016438694
- 3009211636
- 3008624479
- 3005695838
- 3012854006
- 3036756245
- 3010687973
- 3008513917
- 3016112537
- 3004749705
- 9681161
- 2027804
- 3004638532
- 9681387
- 8043816
- 3005182241
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 |
| K901717 | KLEIN MICRO-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| K901718 | KLEIN LAMPREY-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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