The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Calf Implant, Model Ec17-x.
| Device ID | K052505 |
| 510k Number | K052505 |
| Device Name: | CALF IMPLANT, MODEL EC17-X |
| Classification | Elastomer, Silicone Block |
| Applicant | IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura, CA 93003 |
| Contact | Stephen Meade |
| Correspondent | Stephen Meade IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura, CA 93003 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2005-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724SGRTSG31 | K052505 | 000 |
| M724CCB101SIZNS1 | K052505 | 000 |
| M724CCB1021 | K052505 | 000 |
| M724CCB102SIZNS1 | K052505 | 000 |
| M724CCB1031 | K052505 | 000 |
| M724CCB103SIZNS1 | K052505 | 000 |
| M724CCB911 | K052505 | 000 |
| M724CCB91SIZNS1 | K052505 | 000 |
| M724CCB921 | K052505 | 000 |
| M724CCB92SIZNS1 | K052505 | 000 |
| M724CCB931 | K052505 | 000 |
| M724CCB7SIZ2NS1 | K052505 | 000 |
| M724CCB721 | K052505 | 000 |
| M724CCB731 | K052505 | 000 |
| M724CCB711 | K052505 | 000 |
| M724SGRTSG11 | K052505 | 000 |
| M724SGRTSG21 | K052505 | 000 |
| M724CCB1011 | K052505 | 000 |