510(k) K883473
- Device
- SURGICAL CONNECTING TUBES
- Applicant
- WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
- 510(k) number
- K883473
- Product code
- GAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-25
- Date received
- 1988-08-16
- Regulation
- 880.6740
- Classification name
- Tubing, Noninvasive
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIM SAGERS
- Address
- 1253 Ramona St. SE Grand Rapids MI US 49507 49507
FDA Registration Numbers#
- 3033796870
- 2024311
- 1423537
- 3016685880
- 2024022
- 2029275
- 3009882464
- 1526611
- 3006538822
- 9610612
- 3003786160
- 3010069773
- 3003995932
- 1645337
- 1423662
- 3007289408
- 3010216013
- 3013404959
- 3010400865
- 3005391805
- 3015974593
- 3034629649
- 9616250
- 3013499315
- 3036773433
- 3043007473
- 3010805941
- 1825014
- 3007305485
- 3007421149
- 3016851379
- 3019269298
- 1052728
- 3010834934
- 3011050570
- 3017202422
- 2027804
- 3011986317
- 3010202439
- 2032112
- 1721432
- 9616088
- 2032830
- 3019798849
- 3010331645
- 8030673
- 1319639
- 1054241
- 3016884191
- 3007441619
- 1928237
- 8021995
- 8040459
- 3010413216
- 1018470
- 3004001706
- 3017636737
- 3004099493
- 3038611379
- 9611500
- 3009538961
- 3042032212
- 3017567825
- 3004519921
- 3016659819
- 1058726
- 3043534762
- 3017911818
- 3010594263
- 2029015
- 3015989071
- 2183446
- 9614434
- 1921846
- 3003790304
- 1226074
- 9610773
- 1037007
- 3021244152
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952605 | SUCTION/IRRIGATOR TUBING KIT | Surgical Laser Technologies, Inc. | 1995-09-15 |
| K945978 | TUBING, NONINVASIVE | Endoscopic Technologies, Inc. | 1995-01-11 |
| K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | Core Dynamics, Inc. | 1993-07-23 |
| K911865 | NORTEC CONNECTING TUBE SET | North American Sterilization & Packaging Co. | 1991-11-01 |
| K910471 | MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE | Baxter Healthcare Corp | 1991-03-08 |
| K910171 | MAXI-FLOW SUCTION SET W/Y CONNECTOR | Adler Instrument Co. | 1991-02-01 |
| K910170 | MAXI-FLOW SUCTION SET 12 FT. | Adler Instrument Co. | 1991-02-01 |
| K882315 | VIR-A-VAC EMPTY | Viratec Corp. | 1988-09-26 |
| K864964 | 5 - IN - 1 CONNECTOR | Medovations, Inc. | 1987-01-20 |
| K861757 | 5 IN 1 CONNECTOR | Jackson Plastics, Inc. | 1986-06-06 |
| K843476 | PHARMA-PLAST SMOOTH BORE CONNECTORS | Zimmar Consulting , Ltd. | 1984-09-24 |
| K840838 | MMG CONNECTIVE TUBING | Medical Marketing Group | 1984-03-30 |
| K832519 | ASPIRATING TUBING | Wells Johnson Co. | 1983-10-20 |
| K830901 | CONNECTOR 5 IN 1, T-CONNECTOR | Medical Specialists IN Packaging | 1983-04-06 |
| K830835 | STERILE 5 IN 1 CONNECTORS | Abco Dealers, Inc. | 1983-04-06 |
Legacy Summary#
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FDA Review#
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