The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Comply Bowie- Dick Type Lead Free Test Pack.
| Device ID | K093199 |
| 510k Number | K093199 |
| Device Name: | 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Jizhong Jin |
| Correspondent | Jizhong Jin 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2009-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387584165 | K093199 | 000 |
| 50707387584158 | K093199 | 000 |
| 50707387584141 | K093199 | 000 |
| 50707387584134 | K093199 | 000 |