510(k) K863432
- Device
- OXYGEN CANNULA EAR WRAP (STYLE B)
- Applicant
- SALTER LABS
- 510(k) number
- K863432
- Product code
- CAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-18
- Date received
- 1986-09-04
- Regulation
- 868.5340
- Classification name
- Cannula, Nasal, Oxygen
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES N CURTI
- Address
- P.O. Box 608 Arvin CA US 93203 93203
FDA Registration Numbers#
- 3038913749
- 3010131137
- 3015821396
- 3010248787
- 3011503227
- 3038139564
- 3003965134
- 3013783488
- 3008693658
- 3017520736
- 3045058049
- 3013188547
- 3018366470
- 3005652389
- 3031184338
- 3003882387
- 3003932293
- 2225311
- 3013496867
- 3033814505
- 3010889742
- 3006157842
- 9610861
- 3010595915
- 3005998497
- 3006547005
- 8030673
- 9681409
- 3011137372
- 3017171849
- 3010419931
- 1000484830
- 3013576541
- 3009683397
- 8022257
- 8022978
- 3004874794
- 3005587132
- 3010621964
- 3012050423
- 3021039857
- 3010156053
- 3019388613
- 3015058854
- 3007697981
- 3018074706
- 3003887292
- 3010882708
- 2648727
- 9616567
- 2183615
- 9616083
- 1924066
- 3013000203
- 3011529314
- 3006061749
- 3005873568
- 3017207289
- 3017609572
- 3007681502
- 3006467300
- 3027256461
- 3018762668
- 9710020
- 3012316249
- 3008902714
- 3005783425
- 3003902679
- 3001620590
- 3014615175
- 3010198795
- 3034669683
- 3020614
- 3010400865
- 8010042
- 3015928685
- 3013550220
- 3007963782
- 2027062
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | Hudson Respiratory Care, Inc. | 2001-06-13 |
| K935533 | NASAL CANNULA | Puritas Health Care, Inc. | 1994-02-03 |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | Boston Pacific Medical, Inc. | 1993-03-18 |
| K921496 | SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED | Alpine Specialties, Inc. | 1992-08-14 |
| K920573 | CANNULA NASAL OXYGEN | B & F Medical Products, Inc. | 1992-08-11 |
| K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | Specialty Packaging Producs, Inc. | 1991-10-18 |
| K912197 | SKIN SAVER(TM) TUBING HOLDER, MODEL 467 | Alpine Specialties, Inc. | 1991-08-20 |
| K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | Salter Labs | 1991-07-24 |
| K902420 | CATHETER, NASAL, OXYGEN | Gainor Medical Europe, Ltd. | 1991-04-17 |
| K896036 | THE COMFORTABLE CANNULA | Comfortable Concepts Corp. | 1989-11-17 |
| K892435 | KENDALL CURITY OXYGEN NASAL CANNULA | The Kendal Co. | 1989-06-12 |
| K884149 | COMFORT STRAP | Comfort Strap Co. | 1988-10-21 |
| K863431 | OXYGEN CANNULA EAR WRAP (STYLE A) | Salter Labs | 1986-09-18 |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | Andover Medical, Inc. | 1986-04-01 |
| K860872 | NASAL CANNULA W/2M & 5M TUBING | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
Legacy Summary#
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FDA Review#
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