The following data is part of a premarket notification filed by 3m Company with the FDA for Sterigage Model 1243ra, 1243rb, 1243re.
| Device ID | K101249 |
| 510k Number | K101249 |
| Device Name: | STERIGAGE MODEL 1243RA, 1243RB, 1243RE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-05-W-06 St. Paul, MN 55144 -1000 |
| Contact | Suzanne Leung |
| Correspondent | Suzanne Leung 3M COMPANY 3M CENTER, BLDG. 275-05-W-06 St. Paul, MN 55144 -1000 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-04 |
| Decision Date | 2010-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387769241 | K101249 | 000 |
| 50707387785753 | K101249 | 000 |