510(k) K922397
- Device
- 4 SURE TM NASAL OXYGEN CANNULA
- Applicant
- BOSTON PACIFIC MEDICAL, INC.
- 510(k) number
- K922397
- Product code
- CAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-03-18
- Date received
- 1992-05-21
- Regulation
- 868.5340
- Classification name
- Cannula, Nasal, Oxygen
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RANDALL GREEN
- Address
- 636 Beacon St. Unit 204 Boston MA US 02215 02215
FDA Registration Numbers#
- 3006787036
- 3011587055
- 3010882708
- 3030446844
- 3003965134
- 3006547005
- 3011503227
- 3004122598
- 3004056932
- 3003887292
- 8043316
- 3015058854
- 3020614
- 1225580
- 1000484830
- 3005767446
- 3022568093
- 3023209222
- 9680411
- 3015928685
- 3003674698
- 3015515504
- 3013510193
- 3000261882
- 3012971441
- 9616567
- 1314417
- 3013550220
- 3015168843
- 9710020
- 8022032
- 9611500
- 3005609751
- 3010580321
- 8021995
- 3003528228
- 3007092328
- 3011600579
- 3033814505
- 3011529314
- 3011137372
- 3015140199
- 1313525
- 3034629649
- 3038913749
- 3042507287
- 3023339109
- 8040278
- 3006157842
- 3010402691
- 3016618143
- 3004874794
- 9710567
- 3010106508
- 3006899153
- 3013412170
- 3030648305
- 3013507143
- 3010834934
- 3014610488
- 3018503755
- 3034669683
- 3031369651
- 3006563173
- 3013055504
- 3007307487
- 9613418
- 3001313714
- 3011237770
- 3015060216
- 3027256461
- 9710641
- 3007207474
- 3010131137
- 2025816
- 1417592
- 3045058049
- 3006125362
- 3000153466
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 |
| 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 |
| K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | 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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