510(k) K881516
- Device
- Compresaid
- Applicant
- R. EVANS CORP.
- 510(k) number
- K881516
- Product code
- FZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-29
- Date received
- 1988-04-11
- Regulation
- 878.3900
- Classification name
- Splint, Extremity, Inflatable, External
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT J EVANS
- Address
- Suite 209 14040 N. Cave Creek Rd. Phoenix AZ US 85022 85022
FDA Registration Numbers#
- 3004605321
- 3010409218
- 3010339057
- 1026765
- 3005282622
- 1122845
- 1523574
- 3003893701
- 3013527364
- 3010951384
- 3005951403
- 3010182295
- 3005621808
- 1417592
- 3010951382
- 1836161
- 3007774549
- 3030979378
- 3015139841
- 3009567010
- 8022890
- 3013226
- 3010952189
- 3005841961
- 3003516784
- 3010515776
- 3042251628
- 1043214
- 3008773774
- 3011525245
- 3021275665
- 3014301546
- 3010872396
- 3005588647
- 8030607
- 9710391
- 9611559
- 1924066
- 9617759
- 2110420
- 3034694939
- 3006026111
- 3015337116
- 3040314203
- 3014982318
- 3014680784
- 3021282525
- 3005246958
- 3004526603
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FZF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874050 | INFLATABLE FOOT & ANKLE SPLINT | Vinyl Technology, Inc. | 1987-11-23 |
| K874051 | INFLATABLE FULL LEG SPLINT | Vinyl Technology, Inc. | 1987-11-23 |
| K874052 | INFLATABLE HALF LEG SPLINT | Vinyl Technology, Inc. | 1987-11-23 |
| K874053 | INFLATABLE FULL ARM SPLINT | Vinyl Technology, Inc. | 1987-11-23 |
| K853600 | INFLATABLE AIR SPLINTS | Hospitak, Inc. | 1985-09-19 |
| K831764 | URIAS PRESSURE SPLINTS, & FIRST AID | Svenol Andersen | 1983-09-12 |