The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Cell Saver 5 System.
Device ID | K932890 |
510k Number | K932890 |
Device Name: | CELL SAVER 5 SYSTEM |
Classification | Apparatus, Autotransfusion |
Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
Contact | Matthew Nowland |
Correspondent | Matthew Nowland HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-14 |
Decision Date | 1994-01-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30812747016814 | K932890 | 000 |
10812747016025 | K932890 | 000 |
30812747016036 | K932890 | 000 |
30812747016043 | K932890 | 000 |
10812747016063 | K932890 | 000 |
30812747016074 | K932890 | 000 |
30812747016098 | K932890 | 000 |
30812747016104 | K932890 | 000 |
30812747016111 | K932890 | 000 |
30812747016128 | K932890 | 000 |
30812747016135 | K932890 | 000 |
30812747016142 | K932890 | 000 |
30812747016265 | K932890 | 000 |
30812747016272 | K932890 | 000 |
30812747016340 | K932890 | 000 |
30812747016487 | K932890 | 000 |
30812747015169 | K932890 | 000 |