The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Cell Saver Elite Autotransfusion System.
Device ID | K101907 |
510k Number | K101907 |
Device Name: | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM |
Classification | Apparatus, Autotransfusion |
Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
Contact | Greg Calder |
Correspondent | Greg Calder 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 | 2010-07-08 |
Decision Date | 2010-12-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30812747016630 | K101907 | 000 |
30812747016586 | K101907 | 000 |
30812747016579 | K101907 | 000 |
30812747016562 | K101907 | 000 |
30812747016555 | K101907 | 000 |
30812747016548 | K101907 | 000 |
30812747016531 | K101907 | 000 |
30812747016524 | K101907 | 000 |