510(k) K780417
- Device
- ASEPTIC TRANSFER SET
- Applicant
- HEYER SCHULTE CORP.
- 510(k) number
- K780417
- Product code
- GAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-18
- Date received
- 1978-03-14
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009882464
- 2523676
- 3007344957
- 2027062
- 1314417
- 3005099803
- 3012341425
- 3014312726
- 3043534762
- 3006538822
- 3008571754
- 2020550
- 9616250
- 3043007473
- 1836161
- 3006061749
- 3004874794
- 3038356900
- 2024022
- 2024311
- 1825034
- 3041878227
- 3006536657
- 3031231776
- 1423662
- 3006542380
- 3008370577
- 3006142527
- 2032112
- 1043572
- 1820334
- 1017294
- 3004365956
- 3008876063
- 9610773
- 3036773433
- 1037007
- 3017911818
- 3027977504
- 3004530184
- 8044099
- 3043606675
- 1721432
- 3010069773
- 3002579136
- 3014159736
- 9616083
- 3011986317
- 3015177409
- 3035642068
- 3043051314
- 3002808022
- 3044819802
- 3044026004
- 3030447506
- 1647149
- 3004001706
- 1649518
- 9614434
- 3010216013
- 3019269298
- 1054241
- 3004839227
- 1052728
- 3013546453
- 3012185136
- 2953726
- 3005182235
- 3033796870
- 3005841027
- 3009538961
- 3018503755
- 3017636737
- 3010452421
- 9616088
- 1018470
- 2032830
- 3034629649
- 2027804
- 3005391805
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 |
| K910170 | MAXI-FLOW SUCTION SET 12 FT. | Adler Instrument Co. | 1991-02-01 |
| K910171 | MAXI-FLOW SUCTION SET W/Y CONNECTOR | Adler Instrument Co. | 1991-02-01 |
| K882315 | VIR-A-VAC EMPTY | Viratec Corp. | 1988-09-26 |
| K883473 | SURGICAL CONNECTING TUBES | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-08-25 |
| 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 |
| K830835 | STERILE 5 IN 1 CONNECTORS | Abco Dealers, Inc. | 1983-04-06 |
Legacy Summary#
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FDA Review#
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