510(k) K781797
- Device
- PREP TRAY, PREOPERATIVE SKIN
- Applicant
- PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
- 510(k) number
- K781797
- Product code
- OJU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-11-08
- Date received
- 1978-10-23
- Regulation
- 878.4800
- Classification name
- Skin Prep Tray
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004605321
- 1055236
- 3004362278
- 3006673317
- 1047429
- 3007007790
- 3005595283
- 1061124
- 3009203853
- 1417592
- 1928237
- 3026197444
- 1420054
- 8030673
- 3015173212
- 1314417
- 1043214
- 3004111573
- 1030451
- 1423395
- 1643817
- 3035642068
- 1423537
- 3008489813
- 9616088
- 3004519921
- 3004122598
- 1422634
- 2029015
- 2320762
- 3016171914
- 1054241
- 3007329020
- 3009888344
- 3015422337
- 3005012805
- 3005460813
- 3036112794
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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