510(k) K884149
- Device
- Comfort Strap
- Applicant
- COMFORT STRAP CO.
- 510(k) number
- K884149
- Product code
- CAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-21
- Date received
- 1988-10-03
- 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
- ROD CLARK
- Address
- 212 Second Ave. E. Egan SD US 57024 57024
FDA Registration Numbers#
- 3010272829
- 3015173212
- 3012050423
- 2182318
- 3016052406
- 3021947238
- 3007697981
- 3011987967
- 3013226
- 3006636961
- 3003674698
- 1000484830
- 3027256461
- 3042507287
- 8010042
- 3019388613
- 3004134948
- 3013576541
- 3034669683
- 3008363989
- 9616991
- 3010957755
- 3005621808
- 3017609572
- 3010216013
- 3010400865
- 3016068274
- 3013783488
- 3034629649
- 3015772781
- 8022978
- 3006547005
- 3006897996
- 8022257
- 3011503227
- 3005587132
- 3015060216
- 3002912391
- 3003887292
- 1225580
- 3036979319
- 3011237770
- 3010834934
- 3006125362
- 3006395447
- 3017202422
- 3018366470
- 3013510193
- 3000261882
- 3010889742
- 8030673
- 3013412170
- 3011529314
- 3018783526
- 3016758972
- 3009429841
- 3017385563
- 9616445
- 8021995
- 3008776780
- 3003528228
- 3016452400
- 3005873568
- 9680411
- 2225311
- 9611500
- 3013421741
- 3017520736
- 3001313714
- 9710644
- 3006606984
- 3029706818
- 3013188547
- 3015191173
- 3005327291
- 3017896419
- 9610861
- 3008264065
- 3010594263
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 |
| K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | Salter Labs | 1986-09-18 |
| 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 |